FDA.reportPublic FDA data

NDC 68084-964-95 - Propylthiouracil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-964
Requested NDC
68084-964-95
Package NDCs from labels
68084-964-95, 68084-964-25
Manufacturer
American Health Packaging
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Propylthiouracil - American Health PackagingAmerican Health Packaging2026-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-964-25Propylthiouracil30 in 1 BOX, UNIT-DOSETABLET306
68084-964-95Propylthiouracil1 in 1 BLISTER PACKTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-964PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240724_d819e532-09ac-434a-84a6-636c4204c7aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-964-25EA - Each68084-964090b7279-df0b-4fa8-8733-5703f698259b12015-11-12
68084-964-95EA - Each68084-964ad1ba66a-b99e-49f2-9006-51412d70143e12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPYLTHIOURACILACTIVE INGREDIENT721M9407IYPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
PROPYLTHIOURACILACTIVE MOIETY721M9407IYPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 18 · 354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
unii: F05Q2T2JA0
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCd20768fe-4516-483a-a082-ff1df9ad1d992025-12-06Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
unii: F05Q2T2JA0
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
unii: F05Q2T2JA0
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusSENNOSIDES AND DOCUSATE SODIUMGeri-Care Pharmaceutical Corp616a896a-d238-7f7c-e053-2a91aa0a0f5b2025-12-02WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
unii: F05Q2T2JA0
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
unii: F05Q2T2JA0
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.9019ae9e-da3e-4ed1-b83e-d9a6375e9c302025-11-25WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMFamily Dollar (FAMILY WELLNESS)d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c2025-11-25WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLCa7fa9a4b-0fa3-4003-bfb1-8f26ca7109892025-11-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESP & L Development, LLC0cbe3b61-ce35-4be1-9caf-9c61fce10ca22025-11-17WarningsExact identifier
unii: F05Q2T2JA0
good sense stool softenerDOCUSATE SODIUML. Perrigo Company4658d162-6e62-4d84-b5d6-7bf16c9155582025-11-14WarningsExact identifier
unii: F05Q2T2JA0
PROPYLTHIOURACILPROPYLTHIOURACILBryant Ranch Prepacka032648a-a6e4-4356-a483-8eee037790302025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 198175
unii: 721M9407IY
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy1ed3a4d3-629c-4d70-ac03-d0db9f77a9c82025-11-06WarningsExact identifier
unii: F05Q2T2JA0
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.