FDA.reportPublic FDA data

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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ecotrin Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467, 212086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-302-01Ecotrin Regular Strength1 in 1 CARTONTABLET, COATED16
63029-302-01Ecotrin Regular Strength300 in 1 BOTTLE, PLASTICTABLET, COATED3006
63029-302-02Ecotrin Regular Strength125 in 1 BOTTLE, PLASTICTABLET, COATED1256
63029-302-02Ecotrin Regular Strength1 in 1 BOXTABLET, COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-302-01EA - Each63029-302546d14e2-c697-41c3-8078-97008aea248b12022-06-06
63029-302-02EA - Each63029-30286ee756d-d27d-4ed6-a5e2-08a2b256732d12020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
ASPIRINACTIVE MOIETYR16CO5Y76EECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-302ECOTRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]4Current NDC, Legacy NDC, 4 package rows20241127_36cb530b-25b2-4f62-a25d-aa04360815a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN36cb530b-25b2-4f62-a25d-aa04360815a86
212086Ecotrin 325 MG Delayed Release Oral TabletPSN36cb530b-25b2-4f62-a25d-aa04360815a86
212086aspirin 325 MG Delayed Release Oral Tablet [Ecotrin]SBD36cb530b-25b2-4f62-a25d-aa04360815a86
198467aspirin 325 MG Delayed Release Oral TabletSCD36cb530b-25b2-4f62-a25d-aa04360815a86
198467ASA 325 MG Delayed Release Oral TabletSY36cb530b-25b2-4f62-a25d-aa04360815a86
212086ASA 325 MG Delayed Release Oral Tablet [Ecotrin]SY36cb530b-25b2-4f62-a25d-aa04360815a86
198467aspirin 325 MG Enteric Coated Oral TabletSY36cb530b-25b2-4f62-a25d-aa04360815a86
212086Ecotrin 325 MG Delayed Release Oral TabletSY36cb530b-25b2-4f62-a25d-aa04360815a86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-302-01630290302011 BOTTLE, PLASTIC in 1 CARTON (63029-302-01) / 300 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-302-02630290302021 BOTTLE, PLASTIC in 1 BOX (63029-302-02) / 125 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent