FDA.reportPublic FDA data

RAPID RELEASE ACETAMINOPHEN

Product NDC
63981-519
Requested package NDC
63981-519-24
11-digit product format
639810519
Labeler code
63981
Product ID
63981-519_fdb6e160-7960-4982-a721-27118c963f81
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
COSTCO WHOLESALE CORPORATION
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2004-05-10
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage63981-51963981-519-24DDiscontinued 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 · 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-519-05EA - Each63981-5192fa47f5b-6a7b-410f-a443-850a2e0e465912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
ACETAMINOPHENACTIVE MOIETY362O9ITL9DRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
GELATININACTIVE INGREDIENT2G86QN327LRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ERAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [COSTCO WHOLESALE CORPORATION]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-519RAPID RELEASE ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]22Legacy NDC20240417_4fac481f-9782-1127-226b-b8e05a7fff78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-519-24639810519241 BLISTER PACK in 1 CARTON (63981-519-24) > 2 TABLET, COATED in 1 BLISTER PACK1 blister pack2004-05-100000-00-00YesNoCurrent