Acetaminophen

Product NDC
55319-519
11-digit product format
553190519
Labeler code
55319
Product ID
55319-519_92d27c36-6914-429c-85ed-edeebe5a7d37
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Services Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-05-10
Marketing end
2020-08-14
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-519DDiscontinued by firm2026-10-12
excluded packagepackage55319-51955319-519-15DDiscontinued by firm2026-10-12

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 · 24 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 packagepackage55319-519-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-519-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-519-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-519-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-519-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-519-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-519-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-519-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-519-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-519-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-519-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-519-15557ba5c1ecfa…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]11
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR]11