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 23 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN HYVEE INC 3e602287-565e-a5b9-e063-6294a90abc17 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN DELAYED RELEASE 81MG ASPIRIN DELAYED RELEASE 81MG Farmacias De Similares TX LLC 3a8a3efc-f0b3-411c-e063-6394a90a84b7 2026-01-13 Warnings Exact identifier application number: M013 Chewable Aspirin 81 mg ASPIRIN HYVEE INC 459f749f-9d23-8752-e063-6394a90a8c81 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN 325 mg ASPIRIN HYVEE INC 459d01df-6ff6-cff6-e063-6394a90ab35c 2026-01-13 Warnings Exact identifier application number: M013 Pain Terminator Extra Strength Pain Relief CAFFEINE, ACETAMINOPHEN, ASPIRIN Wildman Business Group 8ffb02d9-92df-4d2f-a367-1c71490807fb 2026-01-12 Warnings Exact identifier application number: M013 Aspirin Packs ASPIRIN Sina Health Inc 2865a2c3-53fc-ab9a-e063-6394a90a1418 2026-01-12 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 64696f65-415e-4ce1-a5b3-70662fbcb002 2026-01-12 Warnings Exact identifier application number: M013 Aspirin enteric coated low dose ASPIRIN Walgreen Company 186a6270-e3de-4499-88a4-5f723fee3e34 2026-01-12 Warnings Exact identifier application number: M013 Tension Headache ACETAMINOPHEN, CAFFEINE Cardinal Health 110, LLC. DBA Leader 96684e3f-a13e-49c3-b437-d2627e528a2d 2026-01-12 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Family Dollar Services Inc d35d798e-76f1-454d-86f6-ad11c3bf17d8 2026-01-12 Warnings Exact identifier application number: M013 Xpect Acetaminophen ACETAMINOPHEN Cintas Corporation f4aed854-730e-493d-b523-122156e08dde 2026-01-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN INVAHEALTH INC e5e8a8d5-9174-7975-e053-2a95a90a9aa6 2026-01-08 Warnings Exact identifier application number: M013 Xpect Cold Relief ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL Cintas Corporation 02391d55-32b2-4083-9315-98e9b3650c55 2026-01-08 Warnings Exact identifier application number: M013 pain relief back and body EXTRA STRENGTH ASPIRIN, CAFFEINE Rite Aid Corporation a71392c8-3f5b-4d00-baba-a4055ed68bc1 2026-01-07 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN L.N.K. International, Inc. 8fed703a-9de2-4c76-a783-fcf004f9b890 2026-01-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen c3099892-a8cd-4574-a6f9-041e59e2feae 2026-01-07 Warnings Exact identifier application number: M013 Bactimicina Childrens Pain and Fever ACETAMINOPHEN DLC Laboratories, Inc. bdade270-d813-4178-b594-4951632b6839 2026-01-07 Warnings Exact identifier application number: M013 Goodmeds Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Cabinet Health P.B.C. 02c60967-46d7-49b7-82be-bc3c5fd36484 2026-01-06 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN ARMY AND AIR FORCE EXCHANGE SERVICE a73f8217-9eae-4e2a-b29c-7de3861d0e37 2026-01-06 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation f77f0120-4042-4b11-ba9c-cd35e1cd0bee 2026-01-05 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