FDA.reportPublic FDA data

Aspirin

Product NDC
68016-690
Requested package NDC
68016-690-18
11-digit product format
680160690
Labeler code
68016
Product ID
68016-690_e7f0c8e5-41ee-4b39-a275-bd5382cf046b
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chain Drug Consortium
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1990-09-12
Marketing end
0000-00-00
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
2023-12-31
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 packagepackage68016-69068016-690-18DDiscontinued by firm2026-10-21

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-69068016-690-18DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-690-36EA - Each68016-690d57f081b-877f-489e-adf0-62afe40740fc12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1
DEXTRATESINACTIVE INGREDIENTG263MI44RUASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-690ASPIRIN LOW DOSE (ASPIRIN) TABLET, CHEWABLE [CHAIN DRUG CONSORTIUM]13Legacy NDC20240927_8ffe1a81-56df-45f6-9d65-ec409539cad7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-690-18680160690183 BOTTLE, PLASTIC in 1 CARTON (68016-690-18) > 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC1990-09-120000-00-00NoNoCurrent