Home NDC 63029-302 Ecotrin Regular Strength
Product NDC 63029-302
11-digit product format 630290302
Labeler code 63029
Product ID 63029-302_febaa114-1993-4da9-97d8-4034c0494a92
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, COATED
Route ORAL
Labeler Medtech Products Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-01
Substance ASPIRIN
Active strength 325 mg/1
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 2027-12-31
Current FDA listing Yes 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 Ecotrin Regular Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 325 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198467 Internal RxNorm lookup 212086 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63029-302-01 Ecotrin Regular Strength 1 in 1 CARTON TABLET, COATED 1 6 63029-302-01 Ecotrin Regular Strength 300 in 1 BOTTLE, PLASTIC TABLET, COATED 300 6 63029-302-02 Ecotrin Regular Strength 125 in 1 BOTTLE, PLASTIC TABLET, COATED 125 6 63029-302-02 Ecotrin Regular Strength 1 in 1 BOX TABLET, COATED 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 ASPIRIN ACTIVE MOIETY R16CO5Y76E ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 EDETIC ACID INACTIVE INGREDIENT 9G34HU7RV0 ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63029-302 ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.] 4 Current NDC, Legacy NDC, 4 package rows 20241127_36cb530b-25b2-4f62-a25d-aa04360815a8.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 75 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen Extra Strength ACETAMINOPHEN Family Dollar Stores, LLC f86dcbb8-debc-4bce-e053-6294a90a7a02 2023-12-05 Warnings Exact identifier application number: M013 Sanatos Multi Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBR Pharmadel LLC 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 402c8563-b14b-453f-80bc-4275f1c73702 2023-12-01 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Aurohealth LLC 3ba51b52-7ae6-4335-b178-1b7b6ef36227 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC bc03fa56-8880-4bbd-81a0-91853fecdd4e 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 03d42892-4465-4089-90a7-cd5f00c35602 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Aurohealth LLC 57bb1acc-b9a0-48cd-8e5c-33712441ce81 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN Aurohealth LLC cc0ab7a1-e535-4dc8-962f-c58949fc1737 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC a4ff94b9-c248-4cd3-8491-38e9555cc22e 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC d59c5f04-4bcc-4a52-a42f-e049506f00de 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Extra Strength for Adults ACETAMINOPHEN Aurohealth LLC a769094b-1e91-4ca7-ba67-21aa7e312910 2023-11-29 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Aurohealth LLC 30756257-f748-4a5d-b031-dd267d0f91ad 2023-11-29 Warnings Exact identifier application number: M013 Aurophen Regular Strength ACETAMINOPHEN Aurohealth LLC 8eda893f-5266-4b7a-95b9-2e194973cf06 2023-11-29 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN Aurohealth LLC 00ec6518-b5e3-49d1-a342-139381c3bfd2 2023-11-29 Warnings Exact identifier application number: M013 CHILDRENS PAIN RELIEF ACETAMINOPHEN Better Living Brands, LLC fadb4c09-071f-56c0-e053-6294a90ae6c1 2023-11-28 Warnings Exact identifier application number: M013 Acetaminophen and Diphenhydramine hydrochloride ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Better Living Brands, LLC fc07d516-9ffe-9989-e053-6294a90ae1a5 2023-11-28 Warnings Exact identifier application number: M013 NOTTS - Tension Headache ACETAMINOPHEN, CAFFEINE VIVUNT PHARMA LLC 08f2ae03-967b-ad7e-e063-6294a90a8484 2023-11-24 Warnings Exact identifier application number: M013 Sanatos Multi Symptoms Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0a60326a-a17b-e843-e063-6394a90ac211 2023-11-22 Warnings Exact identifier application number: M013 Sanatos Nighttime Multi Symptoms ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Pharmadel LLC 0ab188f3-f7f9-d665-e063-6294a90a198a 2023-11-22 Warnings Exact identifier application number: M013 ASPIRIN ASPIRIN TIME CAP LABS INC fe12519c-3e5f-4592-bd34-2d6b81b981f4 2023-11-22 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 63029-302-01 63029030201 1 BOTTLE, PLASTIC in 1 CARTON (63029-302-01) / 300 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-06-01 0000-00-00 No No Current 63029-302-02 63029030202 1 BOTTLE, PLASTIC in 1 BOX (63029-302-02) / 125 TABLET, COATED in 1 BOTTLE, PLASTIC 2012-06-01 0000-00-00 No No Current