Home NDC 49483-331 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.
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 Ingredient Strength ASPIRIN 325 mg/3251
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198467 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-331-00 Enteric Coated AspirinRegular Strength 100000 in 1 CARTON TABLET, DELAYED RELEASE 100000 8 49483-331-01 Enteric Coated AspirinRegular Strength 100 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 100 8 49483-331-10 Enteric Coated AspirinRegular Strength 1000 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 1000 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 ASPIRIN ACTIVE MOIETY R16CO5Y76E ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) INACTIVE INGREDIENT 461P5CJN6T ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 5 ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 ASPIRIN ACTIVE MOIETY R16CO5Y76E ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTERIC 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 A INACTIVE INGREDIENT NX76LV5T8J ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ENTERIC 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 INGREDIENT 461P5CJN6T ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ENTERIC 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 NDC Dashboard title SPL version Validation Dashboard ZIP 49483-331 ENTERIC COATED ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [TIME-CAP LABS, INC] 8 Current NDC, Legacy NDC, 3 package rows 20250212_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 56 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Publix Fast Relief Effervescent ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Publix Super Markets Inc. 73051f16-2569-7394-e053-2991aa0a5359 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Effervescent Antacid and Pain Relief ASPIRIN, CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 70d265de-ff94-e0e4-e053-2a91aa0a962a 2024-11-13 Warnings Exact identifier application number: M013 Quality Choice Extra Strength Effervescent Antacid and Pain Relief ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE Chain Drug Marketing Association 9f7d0c96-a561-a8a0-e053-2995a90a250b 2024-11-13 Warnings Exact identifier application number: M013 WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET WinCo Foods, LLC 0c8a755a-089f-477f-97e9-0dd6fdfbe99d 2024-11-13 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Kroger Company 8fb19444-f0e0-4d26-81e8-6a4b835056d8 2024-11-12 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN WALMART INC. 59d01f72-4575-48e2-b914-b6a6456ca7d2 2024-11-11 Warnings Exact identifier application number: M013 pain and fever ACETAMINOPHEN Kroger Company d181560c-1c39-4f2e-8a17-996224ca040f 2024-11-09 Warnings Exact identifier application number: M013 Childrens Tylenol ACETAMINOPHEN Kenvue Brands LLC babcb210-6a47-46ef-b4ea-bdde80411cd3 2024-11-08 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Acme United Corporation f7f9dc46-a945-7ae3-e053-6394a90a1192 2024-11-08 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC dd87e342-b0cb-4111-9f15-415dbcda4b77 2024-11-07 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 0c5fdda8-5049-46de-e063-6294a90a592b 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 46ddbfde-54ab-4373-b832-b9c0620b1e9d 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 333f6231-3778-4c1f-9558-2afddca22c86 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 34247a3b-0846-4086-becd-76e630b3b721 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC a51c2deb-c703-4dc8-9255-8ac9fe635170 2024-11-07 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC ce0a1fbc-7345-462b-b0da-c7149bdc288c 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 015a6179-bacb-452d-b594-4de628ddc11d 2024-11-07 Warnings Exact identifier application number: M013 TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC de5c6654-56c5-40d3-a286-f04ed47ac7c8 2024-11-07 Warnings Exact identifier application number: M013 Midol Complete ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE Acme United Corporation f7bf126d-a6f1-231a-e053-6294a90a04e1 2024-11-07 Warnings Exact identifier application number: M013 CareOne Childrens Acetaminophen ACETAMINOPHEN American Sales Company 49021ae8-9655-4885-9f74-52df4cdcb26f 2024-11-07 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-331-00 49483033100 100000 TABLET, DELAYED RELEASE in 1 CARTON (49483-331-00) 2011-04-10 0000-00-00 No No Current 49483-331-01 49483033101 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-01) 2011-04-10 0000-00-00 No No Current 49483-331-10 49483033110 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-331-10) 2011-04-10 0000-00-00 No No Current