FDA.reportPublic FDA data

Aspirin

Product NDC
69168-372
11-digit product format
691680372
Labeler code
69168
Product ID
69168-372_bdee154f-072f-4735-8fed-8cc46e08dc1f
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-11
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

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
Aspirin
Brand name suffix
Enteric Coated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 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
308416Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cacf02c-9925-40d4-92bc-78788aa0681aAvailable 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
69168-372-06AspirinEnteric Coated120 in 1 BOTTLETABLET1206
69168-372-06AspirinEnteric Coated1 in 1 CARTONTABLET16
69168-372-17AspirinEnteric Coated300 in 1 BOTTLETABLET3006
69168-372-40AspirinEnteric Coated1 in 1 CARTONTABLET16
69168-372-40AspirinEnteric Coated40 in 1 BOTTLETABLET406
69168-372-50AspirinEnteric Coated50 in 1 BOTTLETABLET506
69168-372-50AspirinEnteric Coated1 in 1 CARTONTABLET16
69168-372-99AspirinEnteric Coated365 in 1 BOTTLETABLET3656

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-372ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 8 package rows20240424_8cacf02c-9925-40d4-92bc-78788aa0681a.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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
application number: M013
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN030fb565-2006-a4c3-e063-6394a90a35057
308416aspirin 81 MG Delayed Release Oral TabletSCD030fb565-2006-a4c3-e063-6394a90a35057
308416ASA 81 MG Delayed Release Oral TabletSY030fb565-2006-a4c3-e063-6394a90a35057
308416aspirin 81 MG Enteric Coated Oral TabletSY030fb565-2006-a4c3-e063-6394a90a35057
308416aspirin 81 MG Delayed Release Oral TabletPSN8cacf02c-9925-40d4-92bc-78788aa0681a6
308416aspirin 81 MG Delayed Release Oral TabletSCD8cacf02c-9925-40d4-92bc-78788aa0681a6
308416ASA 81 MG Delayed Release Oral TabletSY8cacf02c-9925-40d4-92bc-78788aa0681a6
308416aspirin 81 MG Enteric Coated Oral TabletSY8cacf02c-9925-40d4-92bc-78788aa0681a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-372-06691680372061 BOTTLE in 1 CARTON (69168-372-06) / 120 TABLET in 1 BOTTLE1 bottle2020-11-110000-00-00NoNoCurrent
69168-372-1769168037217300 TABLET in 1 BOTTLE (69168-372-17) 300 tablet2020-11-110000-00-00NoNoCurrent
69168-372-40691680372401 BOTTLE in 1 CARTON (69168-372-40) / 40 TABLET in 1 BOTTLE1 bottle2022-02-030000-00-00NoNoCurrent
69168-372-50691680372501 BOTTLE in 1 CARTON (69168-372-50) / 50 TABLET in 1 BOTTLE1 bottle2020-11-110000-00-00NoNoCurrent
69168-372-9969168037299365 TABLET in 1 BOTTLE (69168-372-99) 365 tablet2023-12-27NoNoCurrent