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 18 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Enteric Coated ASPIRIN 81 MG Grocery Outlet 79c64e27-87aa-4081-8cbf-343768b00b90 2026-03-19 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE ASPIRIN MAJOR PHARMACEUTICALS 7c24aff7-2b96-27ac-e053-2991aa0a5714 2026-03-19 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack ea417ddb-54b3-49e2-bec1-8fe450d9990c 2026-03-19 Warnings Exact identifier application number: M013 CHILDRENS PAIN AND FEVER ACETAMINOPHEN HyVee Inc 3b08738e-cde2-4843-b609-8f12582c6d08 2026-03-18 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN AND CAFFEINE Salado Sales, Inc. 0666f082-84f3-4041-a322-311188a15670 2026-03-18 Warnings Exact identifier application number: M013 AMAZON BASICS ACETAMINOPHEN ACETAMINOPHEN Amazon.com Services LLC 3c2914a4-913e-7e50-e063-6294a90aff3a 2026-03-18 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack c6cec390-004e-45f6-9388-c662a979f37d 2026-03-17 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Chain Drug Marketing Association, Inc. b32ada58-a098-47d2-9ed2-4d5918657709 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL H E B 21a4cc76-a7cb-4d11-bd1b-7d5c6a332f2a 2026-03-16 Warnings Exact identifier application number: M013 Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Topco Associates, LLC eaa98783-5800-4ae9-832f-f4a1fd1790fd 2026-03-16 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Walgreen Company 413b3b95-2867-4534-8290-54f477cccf1e 2026-03-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Grocery Outlet, Inc. 4454d02a-ba49-6c8c-e063-6294a90a4709 2026-03-12 Warnings Exact identifier application number: M013 Aspirin Enteric Coated ASPIRIN CVS Pharmacy c55304be-bfc0-46a8-a37e-2e6ba9098394 2026-03-12 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Amerisource Bergen c280ac64-920c-4d03-9190-03e0196ed5ef 2026-03-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED d79828d8-9279-4ae9-8872-aeca641be5d9 2026-03-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Preferred Pharmaceuticals Inc. 1b5b8bb1-c45d-48f0-b275-9ce1f769fed4 2026-03-09 Warnings Exact identifier application number: M013 foster and thrive childrens pain and fever ACETAMINOPHEN Strategic Sourcing Services LLC e495a27e-eb64-4c42-8942-43bab9918172 2026-03-07 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL CVS PHARMACY 67a190c3-7de0-4f57-be94-d6b8285e1220 2026-03-06 Warnings Exact identifier application number: M013 Back and Body Pain Relief ASPIRIN, CAFFEINE WinCo Foods, LLC cf5c15e9-c45d-4bd6-a887-fd74de5f81b9 2026-03-06 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN Topco Associates, LLC 87af092c-99e6-475d-81af-b9fd8fc337d7 2026-03-06 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