Pain Reliever

Product NDC
37205-980
11-digit product format
372050980
Labeler code
37205
Product ID
37205-980_80df59b0-86a6-4493-aec4-f418223a5c3c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
CARDINAL HEALTH
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-05-10
Marketing end
2020-08-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37205-980DDiscontinued by firm2026-10-12
excluded packagepackage37205-98037205-980-71DDiscontinued by firm2026-10-12
excluded packagepackage37205-98037205-980-78DDiscontinued 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 · 36 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 packagepackage37205-980-71d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-980-78d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-980-71f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-980-78f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-980-712ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-980-782ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-980-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-980-78a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-980-71cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-980-78cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-980-71cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-980-78cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-980-71302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-980-78302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-980-71ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-980-78ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-980-710efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-980-780efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-980-71ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-980-78ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-980-71367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-980-78367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-980-71557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-980-78557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-980-71EA - Each37205-980d5dc3a65-3323-48fd-aa6c-501b63eecc0a12013-02-13
37205-980-78EA - Each37205-98047e6924c-f69e-47a0-856a-e2fffd27e2c812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CARDINAL HEALTH]8