Acetaminophen

Product NDC
55301-447
11-digit product format
553010447
Labeler code
55301
Product ID
55301-447_b5235361-5d71-4850-88fb-d8a90b833997
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-02-03
Marketing end
2020-11-28
Substance
ACETAMINOPHEN
Active strength
80 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 productproduct55301-447DDiscontinued by firm2026-10-15
excluded packagepackage55301-44755301-447-01DDiscontinued by firm2026-10-15

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 packagepackage55301-447-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55301-447-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55301-447-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55301-447-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55301-447-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55301-447-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55301-447-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55301-447-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55301-447-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55301-447-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55301-447-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55301-447-01557ba5c1ecfa…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 CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ACETAMINOPHEN CHILDREN'S (ACETAMINOPHEN) TABLET, CHEWABLE [ARMY AND AIR FORCE EXCHANGE SERVICE]3