FDA.reportPublic FDA data

Aspirin

Product NDC
59726-227
Requested package NDC
59726-227-03
11-digit product format
597260227
Labeler code
59726
Product ID
59726-227_897aab0a-0ff9-49d3-96e8-c0c87e081903
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
P & L Development, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59726-22759726-227-03DDiscontinued by firm2026-10-20

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, 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…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

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
59726-227-032023-05-11Drug Facts
59726-227-102023-05-11Drug Facts
59726-227-602023-05-11Drug Facts
59726-227-032022-01-28Drug Facts
59726-227-102022-01-28Drug Facts
59726-227-602022-01-28Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4
WATERINACTIVE INGREDIENT059QF0KO0RASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59726-227-0359726022703300 TABLET in 1 BOTTLE (59726-227-03) 300 tablet2013-03-010000-00-00NoNoCurrent