FDA.reportPublic FDA data

Ecotrin

Product NDC
63029-311
11-digit product format
630290311
Labeler code
63029
Product ID
63029-311_1a591668-8b01-438a-8fa1-0f01ede86790
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
81 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416, 1189781

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-311-012020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-142020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-322020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-452020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-652020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-752020-04-20C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-012020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-142020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-322020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-452020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-652020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength
63029-311-752020-01-31C16284748780-19d75b9d1-098a-f424-e053-dadaa90a57ceEcotrin Low Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-311-01Ecotrin1 in 1 CARTONTABLET, COATED15
63029-311-01Ecotrin150 in 1 BOTTLE, PLASTICTABLET, COATED1505
63029-311-14Ecotrin14 in 1 BOTTLE, PLASTICTABLET, COATED145
63029-311-14Ecotrin1 in 1 CARTONTABLET, COATED15
63029-311-32Ecotrin32 in 1 BOTTLE, PLASTICTABLET, COATED325
63029-311-32Ecotrin1 in 1 CARTONTABLET, COATED15
63029-311-45Ecotrin1 in 1 CARTONTABLET, COATED15
63029-311-45Ecotrin45 in 1 BOTTLE, PLASTICTABLET, COATED455
63029-311-65Ecotrin1 in 1 CARTONTABLET, COATED15
63029-311-65Ecotrin365 in 1 BOTTLE, PLASTICTABLET, COATED3655
63029-311-75Ecotrin175 in 1 BOTTLE, PLASTICTABLET, COATED1755
63029-311-75Ecotrin1 in 1 CARTONTABLET, COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-311-32EA - Each63029-3115af8a566-1d61-48e0-a6f6-02c2f0b02dde12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-311ECOTRIN (ASPIRIN) TABLET, COATED [MEDTECH PRODUCTS INC.]5Current NDC, Legacy NDC, 12 package rows20250116_222d187b-aae6-410b-baeb-b2bd42f5c676.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN222d187b-aae6-410b-baeb-b2bd42f5c6765
1189781Ecotrin 81 MG Delayed Release Oral TabletPSN222d187b-aae6-410b-baeb-b2bd42f5c6765
1189781aspirin 81 MG Delayed Release Oral Tablet [Ecotrin]SBD222d187b-aae6-410b-baeb-b2bd42f5c6765
308416aspirin 81 MG Delayed Release Oral TabletSCD222d187b-aae6-410b-baeb-b2bd42f5c6765
308416ASA 81 MG Delayed Release Oral TabletSY222d187b-aae6-410b-baeb-b2bd42f5c6765
1189781ASA 81 MG Delayed Release Oral Tablet [Ecotrin]SY222d187b-aae6-410b-baeb-b2bd42f5c6765
308416aspirin 81 MG Enteric Coated Oral TabletSY222d187b-aae6-410b-baeb-b2bd42f5c6765
1189781Ecotrin 81 MG Delayed Release Oral TabletSY222d187b-aae6-410b-baeb-b2bd42f5c6765
1189781Ecotrin Low Strength 81 MG Delayed Release Oral TabletSY222d187b-aae6-410b-baeb-b2bd42f5c6765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-311-01630290311011 BOTTLE, PLASTIC in 1 CARTON (63029-311-01) / 150 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-311-14630290311141 BOTTLE, PLASTIC in 1 CARTON (63029-311-14) > 14 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-311-32630290311321 BOTTLE, PLASTIC in 1 CARTON (63029-311-32) > 32 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-311-45630290311451 BOTTLE, PLASTIC in 1 CARTON (63029-311-45) / 45 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-311-65630290311651 BOTTLE, PLASTIC in 1 CARTON (63029-311-65) / 365 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
63029-311-75630290311751 BOTTLE, PLASTIC in 1 CARTON (63029-311-75) / 175 TABLET, COATED in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent