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 2 of 18 · 354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
unii: F05Q2T2JA0
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
unii: F05Q2T2JA0
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
unii: F05Q2T2JA0
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESWALMART INC. (see also Equate)43fd4231-0962-4828-a3fa-a1faec81e43d2026-07-15WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
unii: F05Q2T2JA0
Laxative and Stool SoftenerDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)5be43e46-e49b-49eb-a95f-7c4577032f902026-07-13WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.800fa966-077d-4624-9e36-75fe8863dad02026-07-10WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCfc8cf24e-8ca1-b3fb-e053-6294a90a7a502026-07-06WarningsExact identifier
unii: F05Q2T2JA0
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
unii: F05Q2T2JA0
Senna-SDOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MGAarkish Pharmaceuticals NJ Inc.faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f2026-07-01WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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