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 6 of 18 · 354 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESSafeway, Inc.acb40b29-5fd5-4864-b6bf-4102e47a16832026-01-05WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES AND DOCUSATE SODIUMRMT HEALTH LLC4742182e-fdf9-44fe-e063-6394a90adfcc2025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNA-SPioneer Life Sciences, LLCab46a3ca-6c7a-a81e-e053-2995a90a199f2025-12-29WarningsExact identifier
unii: F05Q2T2JA0
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC9e999e4a-2f72-4a2b-a41b-bdd68bf5a3502025-12-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyae9d1672-9ade-4139-9126-5289b87fe5742025-12-17WarningsExact identifier
unii: F05Q2T2JA0
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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