Pain and Fever Relief

Product NDC
51208-001
11-digit product format
512080001
Labeler code
51208
Product ID
51208-001_8b3fc54c-f51c-40ae-84b2-2a998f651f27
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
ScripsAmerica
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-03-18
Marketing end
2020-06-02
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 productproduct51208-001DDiscontinued by firm2026-11-13
excluded packagepackage51208-00151208-001-30DDiscontinued by firm2026-11-13

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 packagepackage51208-001-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51208-001-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51208-001-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51208-001-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51208-001-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51208-001-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51208-001-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51208-001-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51208-001-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51208-001-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51208-001-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51208-001-30557ba5c1ecfa…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 INGREDIENT362O9ITL9DCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
DEXTRATESINACTIVE INGREDIENTG263MI44RUCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS STRENGTH PAIN AND FEVER RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [SCRIPSAMERICA]3