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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-331-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-331-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49483-331-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-331-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-331-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49483-331-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-331-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-331-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49483-331-000efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5fbd8bb3-46f9-4089-9a21-b6af97a06106Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49483-331-002025-02-10331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-012025-02-10331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-102025-02-10331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-002025-01-30331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-012025-01-30331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets
49483-331-102025-01-30331R 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

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 44 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013
Aspirina CafeinaASPIRIN,CAFFEINEBayer HealthCare LLC.2e709acc-325a-baca-e063-6394a90a24be2025-06-12WarningsExact identifier
application number: M013
AspirinASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.696f55b1-536c-40c4-91f7-b572c39220db2025-06-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
application number: M013
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC372be427-acbd-c10c-e063-6294a90a572d2025-06-09WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
application number: M013
Dolo-NeuroBionACETAMINOPHENBENARD INDUSTRIES INCb8310770-84d1-4a6f-8e23-9974947f92f12025-06-04WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATERite Aid Corporation69bda7d7-8660-4e8d-b8ac-892a3b1f21242025-06-03WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENKinderFarms, LLCfb74e8f9-d72f-4681-90bd-df48364405b52025-06-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENP & L Development, LLCb815fcae-8bba-4737-ac10-29a32fb692752025-05-30WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKinderFarms, LLC81cc4900-226b-4c49-ba9c-5747d2a501b12025-05-29WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBryant Ranch Prepacke08a7ab1-4b68-422a-97bd-2c53266339432025-05-29WarningsExact identifier
application number: M013
Acetaminophen GelcapsACETAMINOPHENKroger30d3f2d0-da35-7f6f-e063-6294a90a9c222025-05-23WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.fcffa7e6-145c-6bc0-e053-6294a90a47512025-05-23WarningsExact identifier
application number: M013

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