Aspirin

Product NDC
36800-027
Requested package NDC
36800-027-05
11-digit product format
368000027
Labeler code
36800
Product ID
36800-027_8a9ec9e2-a846-4f07-9a49-686b169534b0
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-15
Marketing end
2022-12-30
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 packagepackage36800-02736800-027-05DDiscontinued 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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17YUnknown FDA exclusion code: Ye2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05YUnknown FDA exclusion code: Y110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
36800-027-052020-11-10DRUG FACTS
36800-027-122020-11-10DRUG FACTS
36800-027-052020-01-31DRUG FACTS
36800-027-122020-01-31DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-027-12EA - Each36800-027fbfeff7d-7c40-40ac-b996-7f37dae423e012017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2
WATERINACTIVE INGREDIENT059QF0KO0RASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-027-05368000027051 BOTTLE, PLASTIC in 1 BOX (36800-027-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC2013-03-152022-12-30NoNoCurrent