Pain Relief

Product NDC
37012-227
Requested package NDC
37012-227-78
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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