Acetaminophen

Product NDC
55319-059
11-digit product format
553190059
Labeler code
55319
Product ID
55319-059_7428e6de-a21c-4252-a1e2-1af1caa643d3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-30
Marketing end
2020-01-31
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-059DDiscontinued by firm2026-10-05
excluded packagepackage55319-05955319-059-00DDiscontinued by firm2026-10-05
excluded packagepackage55319-05955319-059-25DDiscontinued by firm2026-10-05
excluded packagepackage55319-05955319-059-50DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-059-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-059-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-059-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-059-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-059-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-059-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-059-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-059-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-059-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-059-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-059-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-059-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-059-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-059-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-059-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-059-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-059-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-059-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-059-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-059-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-059-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-059-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-059-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-059-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-059-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-059-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-059-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-059-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-059-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-059-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-059-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-059-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-059-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-059-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-059-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-059-00557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
C10-18 TRIGLYCERIDESINACTIVE INGREDIENT43AGM4PHPIACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
TALCINACTIVE INGREDIENT7SEV7J4R1UACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]3