Aspirin

Product NDC
68391-227
11-digit product format
683910227
Labeler code
68391
Product ID
68391-227_22501613-13a3-46c3-8baa-42ec3ced2f32
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
BJWC (Berkley & Jensen / BJ's)
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-31
Marketing end
2024-03-31
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
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 productproduct68391-227DDiscontinued by firm2026-10-05
excluded packagepackage68391-22768391-227-05DDiscontinued 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 · 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 packagepackage68391-227-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68391-227-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68391-227-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68391-227-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68391-227-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68391-227-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68391-227-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68391-227-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68391-227-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68391-227-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68391-227-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68391-227-05557ba5c1ecfa…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 LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3
WATERINACTIVE INGREDIENT059QF0KO0RASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68391-227-05683910227051 BOTTLE, PLASTIC in 1 BOX (68391-227-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC2013-03-312024-03-31NoNoCurrent