Aspirin

Product NDC
63868-354
11-digit product format
638680354
Labeler code
63868
Product ID
63868-354_d0adac1f-d537-4785-8d59-169c59d597f8
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-07-31
Marketing end
2024-02-23
Substance
ASPIRIN
Active strength
81 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 productproduct63868-354DDiscontinued by firm2026-10-16
excluded packagepackage63868-35463868-354-45DDiscontinued by firm2026-10-16

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 packagepackage63868-354-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-354-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-354-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-354-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-354-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-354-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-354-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-354-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-354-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-354-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-354-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-354-45557ba5c1ecfa…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
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN TABLET, COATED [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-354-45638680354451 BOTTLE, PLASTIC in 1 BOX (63868-354-45) > 45 TABLET, COATED in 1 BOTTLE, PLASTIC2014-07-310000-00-00NoNoCurrent