FDA.reportPublic FDA data

Enteric Coated Aspirin

Product NDC
49483-331
11-digit product format
494830331
Labeler code
49483
Product ID
49483-331_2d9d52a2-747c-1f7f-e063-6394a90aa794
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Time-Cap Labs, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-04
Substance
ASPIRIN
Active strength
325 mg/3251
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
Enteric Coated Aspirin
Brand name suffix
Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/3251

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-331-002025-02-10C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-012025-02-10C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-102025-02-10C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-002025-01-30C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-012025-01-30C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-102025-01-30C16284748780-12cef2736-b237-d83d-e063-dadaa90ab31f331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-331-00Enteric Coated AspirinRegular Strength100000 in 1 CARTONTABLET, DELAYED RELEASE1000008
49483-331-01Enteric Coated AspirinRegular Strength100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1008
49483-331-10Enteric Coated AspirinRegular Strength1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-331-01EA - Each49483-3314cadaf05-9066-48aa-9702-2f3912b10d1b12014-06-03
49483-331-10EA - Each49483-331e229c0f3-6ea0-40b7-82ac-3e47bb1ccbf012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]5
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-331ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC]8Current NDC, Legacy NDC, 3 package rows20250212_5fbd8bb3-46f9-4089-9a21-b6af97a06106.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN5fbd8bb3-46f9-4089-9a21-b6af97a061068
198467aspirin 325 MG Delayed Release Oral TabletPSNfd256c4a-a176-45dc-b757-fc01eb1050088
198467aspirin 325 MG Delayed Release Oral TabletSCD5fbd8bb3-46f9-4089-9a21-b6af97a061068
198467aspirin 325 MG Delayed Release Oral TabletSCDfd256c4a-a176-45dc-b757-fc01eb1050088
198467ASA 325 MG Delayed Release Oral TabletSY5fbd8bb3-46f9-4089-9a21-b6af97a061068
198467ASA 325 MG Delayed Release Oral TabletSYfd256c4a-a176-45dc-b757-fc01eb1050088
198467aspirin 325 MG Enteric Coated Oral TabletSY5fbd8bb3-46f9-4089-9a21-b6af97a061068
198467aspirin 325 MG Enteric Coated Oral TabletSYfd256c4a-a176-45dc-b757-fc01eb1050088
198467aspirin 325 MG Delayed Release Oral TabletPSNe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467aspirin 325 MG Delayed Release Oral TabletSCDe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467ASA 325 MG Delayed Release Oral TabletSYe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467aspirin 325 MG Enteric Coated Oral TabletSYe05140fa-9766-4f97-bffc-e36a01b9d38f7
198467aspirin 325 MG Delayed Release Oral TabletPSN51b11ee1-f881-4e12-8298-6994414ce0f76
198467aspirin 325 MG Delayed Release Oral TabletSCD51b11ee1-f881-4e12-8298-6994414ce0f76
198467ASA 325 MG Delayed Release Oral TabletSY51b11ee1-f881-4e12-8298-6994414ce0f76
198467aspirin 325 MG Enteric Coated Oral TabletSY51b11ee1-f881-4e12-8298-6994414ce0f76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-331-0049483033100100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00) 2011-04-100000-00-00NoNoCurrent
49483-331-0149483033101100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-01) 2011-04-100000-00-00NoNoCurrent
49483-331-10494830331101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-10) 2011-04-100000-00-00NoNoCurrent