FDA.reportPublic FDA data

Aspirin

Product NDC
41520-228
Requested package NDC
41520-228-14
11-digit product format
415200228
Labeler code
41520
Product ID
41520-228_4ac68f4c-1acf-48c8-837b-fcf996adfb85
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-04-30
Marketing end
2024-03-29
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-22841520-228-14DDiscontinued 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RASPIRIN ENTERIC SAFETY COATED (ASPIRIN) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41520-228-14415200228141 BOTTLE, PLASTIC in 1 BOX (41520-228-14) > 144 TABLET in 1 BOTTLE, PLASTIC2014-04-302024-03-29NoNoCurrent