Aspirin

Product NDC
49483-349
11-digit product format
494830349
Labeler code
49483
Product ID
49483-349_7cff0ad4-677a-03f7-e053-2a91aa0af7ae
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-12-23
Substance
ASPIRIN
Active strength
81 mg/811
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
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/811

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
70d8ba6c-8dfe-402a-817d-22544141d160Available 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
49483-349-00AspirinDelayed Release100000 in 1 CARTONTABLET, DELAYED RELEASE1000003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-349ASPIRIN DELAYED RELEASE (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]3Current NDC, Legacy NDC, 1 package rows20181215_70d8ba6c-8dfe-402a-817d-22544141d160.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 Delayed ReleaseASPIRINTime-Cap Labs, Inc70d8ba6c-8dfe-402a-817d-22544141d1602018-12-14WarningsExact identifier
ndc (product): 49483-349

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN70d8ba6c-8dfe-402a-817d-22544141d1603
308416aspirin 81 MG Delayed Release Oral TabletSCD70d8ba6c-8dfe-402a-817d-22544141d1603
308416ASA 81 MG Delayed Release Oral TabletSY70d8ba6c-8dfe-402a-817d-22544141d1603
308416aspirin 81 MG Enteric Coated Oral TabletSY70d8ba6c-8dfe-402a-817d-22544141d1603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-349-0049483034900100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-349-00) 2018-12-140000-00-00NoNoCurrent