Others titles

  • DailyMed Drugs Labeling
  • FDA Approved Drugs Labeling

Keywords

  • Structured Product Labeling
  • FDA Drug Labeling Information
  • Product Labeling
  • SPL
  • DailyMed

Structured Product Labeling

The Structured Product Labeling dataset contains the most recent drug labeling information submitted to the Food and Drug Administration (FDA) and currently in use.
All labels information are published by DailyMed the official provider of FDA label information.

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Description

The Structured Product Labeling dataset includes current drug labeling information like Product Name, Ingredients, Route of Administration, Package description and Indications approved by FDA for marketed products.
The regulations require that the content of labeling be submitted in a form that FDA can process, review, and archive.
Since 1999, FDA has been receiving the electronic content of labeling in Portable Document Format (PDF), and this format has allowed FDA to process, review
and archive the content of labeling.
FDA, working with other parties in HL7 (experts from HL7, industry, and technology solution providers), has adapted CDA for labeling in an HL7 standard called Structured Product Labeling (SPL). When compared with PDF, SPL exhibits the following advantages.
– SPL allows the exchange of information between computer systems in a way that cannot be accomplished with PDF. For example, the information in SPL can be used to support health information technology initiatives for improving patient care.
– The exchange of labeling changes with SPL can be easier and more efficient for both FDA and manufacturers when compared with PDF. For example, with SPL, only those sections or data elements of the labeling that are changed would need to be checked rather than the entire labeling.
– SPL allows automation of comparison of text by section and comparison of specific drug information data elements.
– SPL can also be used to exchange information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.

About this Dataset

Data Info

Date Created

2006-01

Last Modified

2024-06-10

Version

2024-06

Update Frequency

Monthly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; DailyMed, National Library of Medicine (NLM);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Structured Product Labeling, FDA Drug Labeling Information, Product Labeling, SPL, DailyMed

Other Titles

DailyMed Drugs Labeling, FDA Approved Drugs Labeling

Data Fields

Name Description Type Constraints
Product_NameThe Name of the productstring-
Product_TypeProduct type (Human/Animal, OTC/Prescription...)string-
IngredientsList of the ingredients of the productstring-
Route_Of_AdministrationRoute of Administration of the productstring-
Appearance_ShapeShape of the product (unit)string-
Appearance_SizeSize of the product (unit)string-
Appearance_ScoreProduct Characteristics: scorestring-
Package_DescriptionPackage Description of the productstring-
Dosage_FormDosage Form of the Productstring-
IndicationsIndications and Usage of the productstring-
ContraindicationsContraindications of the productstring-
Controlled_Substance_CodeControlled Substance Code in the product if includedstring-

Data Preview

Product NameProduct TypeIngredientsRoute Of AdministrationAppearance ShapeAppearance SizeAppearance ScorePackage DescriptionDosage FormIndicationsContraindicationsControlled Substance Code
PROMETHAZINE HYDROCHLORIDEHUMAN PRESCRIPTION DRUGPROMETHAZINEHYDROCHLORIDE12.5mg,SILICONDIOXIDE,EDETATEDISODIUM,HYPROMELLOSE,LACTOSEMONOHYDRATE,MAGNESIUMSTEARATE,CELLULOSE,MICROCRYSTALLINE,SACCHARINSODIUM,SODIUMSTARCHGLYCOLATETYPEAPOTATO,FD&CYELLOWNO.5,FD&CYELLOWNO.6ORALROUND8 mm2.010 in 1 BOTTLE;30 in 1 BOTTLE;75 in 1 BOTTLEPromethazine Hydrochloride Tablets, USP are available as follows: 12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000. 25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500. 50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.Promethazine hydrochloride tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
NitrogenHUMAN PRESCRIPTION DRUGNitrogen995mLENDOSINUSIAL160 L in 1 DEWAR;180 L in 1 DEWAR;230 L in 1 DEWAR;240 L in 1 DEWAR;396 L in 1 CYLINDER;654 L in 1 CYLINDER;2265 L in 1 CYLINDER;3257 L in 1 CYLINDER;6514 L in 1 CYLINDER;5609 L in 1 CYLINDER
NABUMETONEHUMAN PRESCRIPTION DRUGNABUMETONE750mg,SILICONDIOXIDE,D&CYELLOWNO.10,HYPROMELLOSE,MAGNESIUMSTEARATE,CELLULOSE,MICROCRYSTALLINE,POLYETHYLENEGLYCOL,POLYSORBATE80,SODIUMLAURYLSULFATE,SODIUMSTARCHGLYCOLATETYPEAPOTATO,TITANIUMDIOXIDE,FD&CYELLOWNO.6ORALOVAL19 mm1.020 in 1 BOTTLE;30 in 1 BOTTLE;45 in 1 BOTTLE;56 in 1 BOTTLE;60 in 1 BOTTLE;90 in 1 BOTTLENabumetone Tablets are available as light yellow, oval shaped, film coated, unscored tablets, debossed “P649” on one side and “500” on the other side containing 500 mg of nabumetone, packaged in bottles of 100 (NDC 49884-649-01) and 500 (NDC 49884-649-05) tablets. Nabumetone Tablets are available as dark yellow, oval shaped, film coated, unscored tablets, debossed “P650”on one side and “750” on the other side containing 750 mg of nabumetone, packaged in bottles of 100 (NDC 49884-650-01) and 500 (NDC 49884-650-05) tablets. PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure (as required). Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59-86°F) in well-closed container; dispense in light resistant containerCarefully consider the potential benefits and risks of nabumetone and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
PREDNISONEHUMAN PRESCRIPTION DRUGPREDNISONE10mgORALROUND9 mm2.021 in 1 BLISTER PACK;24 in 1 BLISTER PACK;1 in 1 CARTON;2 in 1 CARTONPrednisone Tablets USP, 5 mg: White, round tablets, scored on one side and “West-ward 475” debossed on the other side. Each tablet contains 5 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-733-21 Blister Pack of 48 tablets NDC# 45802-733-67 Prednisone Tablets USP, 10 mg: White, round tablets, scored on one side and “West-ward 473” debossed on the other side. Each tablet contains 10 mg of prednisone for oral administration. Blister Pack of 21 tablets NDC# 45802-303-21 Blister Pack of 48 tablets NDC# 45802-303-67 Store at 20-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: West-ward Pharmaceutical Corporation Eatontown, NJ 07724 DISTRIBUTED BY PERRIGO® ALLEGAN, MI 49010 PREDNISONE TABLETS Revised 09/07 0P800 RC J4Prednisone tablets are indicated in the following conditions: Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; post-traumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loeffler’s syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, eythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephritic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.
CEFADROXILHuman Prescription Drug LabelCEFADROXIL500mg,LACTOSEMONOHYDRATE,MAGNESIUMSTEARATE,FD&CBLUENO.1,D&CREDNO.28,FD&CREDNO.40,TITANIUMDIOXIDE,GELATIN,SODIUMLAURYLSULFATE,FERROSOFERRICOXIDEORALCAPSULE21 mm1.05 in 1 BOTTLE;10 in 1 BOTTLE;14 in 1 BOTTLE;15 in 1 BOTTLE;20 in 1 BOTTLE;30 in 1 BOTTLE
CLOTRIMAZOLEHUMAN PRESCRIPTION DRUGSORBITANMONOSTEARATE,CLOTRIMAZOLE10mg,POLYSORBATE60,CETYLESTERSWAX,CETOSTEARYLALCOHOL,OCTYLDODECYLSTEARATE,WATER,BENZYLALCOHOLTOPICAL15 g in 1 TUBE;30 g in 1 TUBEClotrimazole Cream USP, 1% is supplied in 15, 30, 45, and (2 × 45) gram tubes. Store between 2°- 30°C (36°- 86°F). CAUTION: Federal law prohibits dispensing without prescription. Mfd. by: TARO Pharmaceuticals Inc., Bramalea, Ontario, Canada L6T 1C3 Revision Date: June, 1996Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.Clotrimazole Cream is contraindicated in individuals sensitive to its components.
Oral-B Minute-Foam Orang-A-TangyHUMAN PRESCRIPTION DRUGSodiumFluoride10mg,HydrofluoricAcid2.3mgDENTAL165 g in 1 BOTTLEHOW SUPPLIED: Minute-Foam is available in a 165 g (5.8 oz) plastic aerosol container in six different flavors; NDC 0041-0340-06 Banana Splitz, NDC 0041-03141-06 Mellow Mint, NDC 0041-0342-06 Orang-a-Tangy, NDC 0041-0345-06 Bubblegum, NDC 0041-0346-06 Strawberry, NDC 0041-0347-06 Grape Punch.INDICATIONAND USE: A topically-appliedfoaming solution to aid in the prevention of dental caries.CONTRAINDICATIONS: Do not use in patients with hypersensitivityto fluoride. Do not use in patients withdysphagia.
MetaxaloneHUMAN PRESCRIPTION DRUGMETAXALONE800mg,ALGINICACID,STARCH,CORN,MAGNESIUMSTEARATEORALCAPSULE19 mm1.030 in 1 BOTTLE, PLASTIC;60 in 1 BOTTLE, PLASTIC;90 in 1 BOTTLE, PLASTICMetaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59". They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only. Manufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite AFlowood, MS 39232United StatesMetaxalone tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic or other anemias. Significantly impaired renal or hepatic function.Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants and have been reported with this class of drug in combination with alcohol. When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. Treatment Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
SucralfateHUMAN PRESCRIPTION DRUGSUCRALFATE1g,STARCH,CORN,MAGNESIUMSTEARATE,CELLULOSE,MICROCRYSTALLINEORALOVAL19 mm2.030 in 1 BOTTLE;60 in 1 BOTTLE;120 in 1 BOTTLE;180 in 1 BOTTLESucralfate tablets, USP are supplied as white, single-scored, capsule-shaped tablets containing 1 gram of sucralfate. Available in bottles of: Tablets are debossed “BIOCRAFT” on one side and “105” twice on the scored side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured By: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 5/2007 Repackaging and Relabeling by:Physicians Total Care, Inc.Tulsa, OK 74146Sucralfate is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.There are no known contraindications to the use of sucralfate.
VeramystHUMAN PRESCRIPTION DRUGFLUTICASONEFUROATE27.5ug,BENZALKONIUMCHLORIDE,ANHYDROUSDEXTROSE,EDETATEDISODIUM,CELLULOSE,MICROCRYSTALLINE,CARBOXYMETHYLCELLULOSESODIUM,POLYSORBATE80,WATERNASAL120 in 1 BOTTLE, PLASTIC;1 in 1 BOXVERAMYST Nasal Spray, 27.5 mcg per spray, is supplied in a brown glass bottle enclosed in a nasal device with a nozzle and a mist-release button to actuate the spray in a box of 1 (NDC 54868-6168-0) with FDA-Approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 10 g of white, liquid suspension and will provide 120 metered sprays. After priming [see Dosage and Administration (2)], each spray delivers a fine mist containing 27.5 mcg of fluticasone furoate in 50 microliters of formulation through the nozzle. The contents of the bottle can be viewed through an indicator window. Shake the contents well before each use. The correct amount of medication in each spray cannot be assured before the initial priming and after 120 sprays have been used, even though the bottle is not completely empty. The nasal device should be discarded after 120 sprays have been used. Store the device in the upright position with the cap in place between 15° and 30°C (59° and 86°F). Do not freeze or refrigerate.VERAMYST® (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.VERAMYST Nasal Spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3)] .