FDA.reportPublic FDA data

Enteric Coated Aspirin

Product NDC
53943-081
11-digit product format
539430081
Labeler code
53943
Product ID
53943-081_249d869c-d17e-ebcb-e063-6394a90a94b6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-18
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

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
Enteric Coated Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
53943-081-02Enteric Coated Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE13
53943-081-02Enteric Coated Aspirin125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-081ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [DISCOUNT DRUG MART]3Current NDC, Legacy NDC, 2 package rows20241018_03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48.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 43 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINAdvanced Rx LLCad0d6a5c-eee9-406c-8d7f-1df9b45f53402025-07-02WarningsExact identifier
application number: M013
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
application number: M013
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
application number: M013
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINUnited Natural Foods, Inc. dba UNFI979973c1-661a-4384-8b92-fd901ebde5582025-07-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
application number: M013
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
application number: M013
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013
CHILDRENS ACETAMINOPHENCHILDRENS ACETAMINOPHEN ORALAARNA USA INC.38070d15-2678-4e59-e063-6294a90ab6902025-06-20WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENMorning Star OTC8502ea21-937d-4b33-a3e0-ffab5dc38cd82025-06-19WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTC6cd07a01-7034-4994-bbd3-bedcdf7d5b832025-06-19WarningsExact identifier
application number: M013
DRX CHOICE Tension HeadacheACETAMINOPHEN, CAFFEINERaritan Pharmaceuticals Inc.8a5cb38b-669d-4177-b33b-d73c7ef48d182025-06-13WarningsExact identifier
application number: M013
good sense childrens pain and feverACETAMINOPHENNuCare Pharmaceuticals,Inc.3777f4fb-d279-199d-e063-6394a90acf362025-06-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN03ed19dd-1cfc-47d5-b83e-ffa2ebe93f483
198467aspirin 325 MG Delayed Release Oral TabletSCD03ed19dd-1cfc-47d5-b83e-ffa2ebe93f483
198467ASA 325 MG Delayed Release Oral TabletSY03ed19dd-1cfc-47d5-b83e-ffa2ebe93f483
198467aspirin 325 MG Enteric Coated Oral TabletSY03ed19dd-1cfc-47d5-b83e-ffa2ebe93f483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-081-02539430081021 BOTTLE, PLASTIC in 1 CARTON (53943-081-02) / 125 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2010-01-180000-00-00NoNoCurrent