FDA.reportPublic FDA data

Aspirin

Product NDC
67091-123
11-digit product format
670910123
Labeler code
67091
Product ID
67091-123_28609334-09b4-3ac4-e063-6394a90ae583
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Low Dose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-123-12AspirinLow Dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1203
67091-123-12AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-123ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WINCO FOODS, LLC]3Current NDC, Legacy NDC, 2 package rows20241206_4359da13-e851-440b-91b9-6b544bff20d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN4359da13-e851-440b-91b9-6b544bff20d23
308416aspirin 81 MG Delayed Release Oral TabletSCD4359da13-e851-440b-91b9-6b544bff20d23
308416ASA 81 MG Delayed Release Oral TabletSY4359da13-e851-440b-91b9-6b544bff20d23
308416aspirin 81 MG Enteric Coated Oral TabletSY4359da13-e851-440b-91b9-6b544bff20d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-123-12670910123121 BOTTLE, PLASTIC in 1 CARTON (67091-123-12) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2014-12-150000-00-00NoNoCurrent