Pain Relief

Product NDC
37012-227
11-digit product format
370120227
Labeler code
37012
Product ID
37012-227_af64da69-04e1-41eb-93c3-db78be39bc7d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-12-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct37012-227DDiscontinued by firm2026-10-05
excluded packagepackage37012-22737012-227-78DDiscontinued 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 · 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 packagepackage37012-227-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-227-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-227-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-227-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-227-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-227-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-227-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-227-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-227-780efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-227-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-227-78367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-227-78557ba5c1ecfa…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 INGREDIENT362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-227-78370120227781 BOTTLE in 1 CARTON (37012-227-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-12-110000-00-00NoNoCurrent