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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
36cb530b-25b2-4f62-a25d-aa04360815a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63029-302-01	EA - Each	63029-302	546d14e2-c697-41c3-8078-97008aea248b	1	2022-06-06
63029-302-02	EA - Each	63029-302	86ee756d-d27d-4ed6-a5e2-08a2b256732d	1	2020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 71 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Tension Headache	ACETAMINOPHEN, CAFFEINE	Haleon US Holdings LLC	12c074d1-81ac-47d2-8747-b018cda0058a	2024-03-13	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Strive Pharmaceuticals Inc.	78c12459-3b27-4ed0-943d-520794eb438d	2024-03-07	Warnings	Exact identifier application number: M013
Pain Reliever fever Reducer Extra Strength	ACETAMINOPHEN	CVS Pharmacy	7b5263ad-01b7-4fc5-9384-4da8efe89e35	2024-03-06	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	11a8439b-0159-4351-b0f5-fe7fad6a33c0	2024-03-05	Warnings	Exact identifier application number: M013
Winco Foods Effervescent Pain Relief	ASPIRIN	Winco Foods, LLC	128afdd7-a9d1-8957-e063-6294a90af569	2024-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	Care One (Retail Business Services, LLC.)	6659e103-fa03-4de0-af42-d2fbd548a87c	2024-03-05	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198467	aspirin 325 MG Delayed Release Oral Tablet	PSN	36cb530b-25b2-4f62-a25d-aa04360815a8	6
212086	Ecotrin 325 MG Delayed Release Oral Tablet	PSN	36cb530b-25b2-4f62-a25d-aa04360815a8	6
212086	aspirin 325 MG Delayed Release Oral Tablet [Ecotrin]	SBD	36cb530b-25b2-4f62-a25d-aa04360815a8	6
198467	aspirin 325 MG Delayed Release Oral Tablet	SCD	36cb530b-25b2-4f62-a25d-aa04360815a8	6
198467	ASA 325 MG Delayed Release Oral Tablet	SY	36cb530b-25b2-4f62-a25d-aa04360815a8	6
212086	ASA 325 MG Delayed Release Oral Tablet [Ecotrin]	SY	36cb530b-25b2-4f62-a25d-aa04360815a8	6
198467	aspirin 325 MG Enteric Coated Oral Tablet	SY	36cb530b-25b2-4f62-a25d-aa04360815a8	6
212086	Ecotrin 325 MG Delayed Release Oral Tablet	SY	36cb530b-25b2-4f62-a25d-aa04360815a8	6

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