FDA.reportPublic FDA data

aspirin

Product NDC
49483-390
11-digit product format
494830390
Labeler code
49483
Product ID
49483-390_7d3f7c1d-79ea-acce-e053-2a91aa0acd38
Type
HUMAN OTC DRUG
Nonproprietary name
aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-07-16
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 enteric coated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7146c505-2469-4bc2-9e1e-ceb60951c8aeAvailable on FDA.report

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
49483-390-00aspirinlow dose enteric coated100000 in 1 CARTONTABLET1000002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIR LOW (ASPIRIN) TABLET [UNIT DOSE SERVICES]2
aspirinACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET [TIME-CAP LABS, INC]1
aspirinACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-390ASPIRIN LOW DOSE ENTERIC COATED (ASPIRIN) TABLET [TIME-CAP LABS, INC]2Current NDC, Legacy NDC, 1 package rows20181218_7146c505-2469-4bc2-9e1e-ceb60951c8ae.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc7146c505-2469-4bc2-9e1e-ceb60951c8ae2018-12-17WarningsExact identifier
ndc (product): 49483-390

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293665Aspir Low 81 MG Delayed Release Oral TabletPSN50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Delayed Release Oral TabletPSN50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Delayed Release Oral TabletPSN7146c505-2469-4bc2-9e1e-ceb60951c8ae2
1293665aspirin 81 MG Delayed Release Oral Tablet [Aspir-Low]SBD50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Delayed Release Oral TabletSCD50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Delayed Release Oral TabletSCD7146c505-2469-4bc2-9e1e-ceb60951c8ae2
308416ASA 81 MG Delayed Release Oral TabletSY50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416ASA 81 MG Delayed Release Oral TabletSY7146c505-2469-4bc2-9e1e-ceb60951c8ae2
1293665ASA 81 MG Delayed Release Oral Tablet [Aspir-Low]SY50c157d7-ea12-4a55-82ba-4190bd1fd4c52
1293665Aspir-Low 81 MG Delayed Release Oral TabletSY50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Enteric Coated Oral TabletSY50c157d7-ea12-4a55-82ba-4190bd1fd4c52
308416aspirin 81 MG Enteric Coated Oral TabletSY7146c505-2469-4bc2-9e1e-ceb60951c8ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-390-0049483039000100000 TABLET in 1 CARTON (49483-390-00) 100000 tablet2018-12-170000-00-00NoNoCurrent