FDA.reportPublic FDA data

Aspirin

Product NDC
68016-089
11-digit product format
680160089
Labeler code
68016
Product ID
68016-089_e6401018-b6f1-46d8-8ad7-69d26268c976
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-03-22
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct68016-089DDiscontinued by firm2026-10-05
excluded packagepackage68016-08968016-089-03DDiscontinued 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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-089-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-089-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-089-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-089-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-089-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-089-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-089-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-089-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-089-03DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-089-03DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-089-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-089-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68016-089-03IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68016-089-03IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68016-089-03IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-089-03IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-089-03IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-089-03IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68016-089-03IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68016-089-03IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-089-03IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68016-089-03EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-089-032024-10-09C16284748780-19d75b9d0-d276-f424-e053-dadaa90a57ceDRUG FACTS
68016-089-032020-01-31C16284748780-19d75b9d0-d276-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG CONSORTIUM, LLC]4