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 57 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dg health pain relief	ACETAMINOPHEN	Dolgencorp, LLC	382fa2cc-1c39-4bee-b528-08b11ec945af	2024-11-02	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	f7e20527-1d4b-434c-997b-3eb8211fdaa1	2024-11-01	Warnings	Exact identifier application number: M013
Aspirin Enteric Safety Coated	ASPIRIN	Publix Supermarkets, Inc.	a661a9ed-9b31-46b1-aafb-61d1ba8a4918	2024-11-01	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	614e69c7-d3cb-4d47-9603-c1c14b87544c	2024-11-01	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	baee03b8-fcfd-440e-90ea-1ee2a18516ef	2024-11-01	Warnings	Exact identifier application number: M013
good neighbor pharmacy infants pain and fever	ACETAMINOPHEN	Amerisource Bergen	bfb954b7-3a79-4bca-95e8-d39e1074b07f	2024-11-01	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEVER	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Proficient Rx LP	bf365bfc-35cc-47f9-a50b-ff2b38d7316b	2024-11-01	Warnings	Exact identifier application number: M013
Infants Pain Relief	ACETAMINOPHEN	Publix Super Markets Inc	0bc33897-afc2-4d11-be6c-a26480f448bf	2024-10-31	Warnings	Exact identifier application number: M013
equate infants pain and fever	ACETAMINOPHEN	WALMART INC.	34b2512e-743b-45db-92cb-ea05e2f47b3d	2024-10-31	Warnings	Exact identifier application number: M013
foster and thrive infants pain and fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	45770ad6-9bf7-41bd-a724-e5260cd31fa1	2024-10-31	Warnings	Exact identifier application number: M013
Midol Complete	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET	Lil' Drug Store Products, Inc.	d20425a4-f074-4154-e053-2995a90ae9fd	2024-10-30	Warnings	Exact identifier application number: M013
up and up infants acetaminophen	ACETAMINOPHEN	Target Corporation	31104956-04d7-41b5-82be-219ded5c02a9	2024-10-30	Warnings	Exact identifier application number: M013
Sunmark Aspirin	ASPIRIN	Strategic Sourcing Services LLC	a7139686-b351-47dc-a395-832429aaa569	2024-10-30	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1	2024-10-30	Warnings	Exact identifier application number: M013
Acetaminophen	PAIN RELIEVER	McKesson	9d620700-5d00-475f-e053-2995a90a9a3f	2024-10-28	Warnings	Exact identifier application number: M013
Junior Acetaminophen Ages 6-11	ACETAMINOPHEN	Chain Drug Consortium	d356bc9c-66f1-45c3-a455-98c0b8890f78	2024-10-28	Warnings	Exact identifier application number: M013
leader Acetaminophen	ACETAMINOPHEN	Cardinal Health 110, LLC. dba Leader	36bdcac9-eed4-40f9-a6f2-4c1e773a6b50	2024-10-25	Warnings	Exact identifier application number: M013
GOODYS PM	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	Medtech Products Inc.	db5d6c2b-688e-4e88-a42d-0fa2b0d8140b	2024-10-25	Warnings	Exact identifier application number: M013
Goodys Extra Strength	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Medtech Products Inc.	16d774cc-4247-4bf8-9b5a-c338ffebda3d	2024-10-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	PUBLIX SUPER MARKETS INC	9e77ab7a-07e8-42aa-e053-2995a90a0d0e	2024-10-24	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