FDA.reportPublic FDA data

Aspirin

Product NDC
55910-945
11-digit product format
559100945
Labeler code
55910
Product ID
55910-945_11145838-fe47-494e-90da-3986695661e2
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-25
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
55910-945-12AspirinLow Dose100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10013
55910-945-12AspirinLow Dose1 in 1 CARTONTABLET, DELAYED RELEASE113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN 81 MG NSAID LOW DOSE (ASPIRIN) TABLET, COATED [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-945ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [DOLGENCORP, LLC]12Current NDC, Legacy NDC, 2 package rows20241116_7396c97e-8a51-4a21-8208-f13258b5285c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN7396c97e-8a51-4a21-8208-f13258b5285c13
308416aspirin 81 MG Delayed Release Oral TabletSCD7396c97e-8a51-4a21-8208-f13258b5285c13
308416ASA 81 MG Delayed Release Oral TabletSY7396c97e-8a51-4a21-8208-f13258b5285c13
308416aspirin 81 MG Enteric Coated Oral TabletSY7396c97e-8a51-4a21-8208-f13258b5285c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55910-945-12559100945121 BOTTLE, PLASTIC in 1 CARTON (55910-945-12) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2014-07-250000-00-00NoNoCurrent