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 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC01f41fae-4abb-4b96-ab09-a7d3dfc286cd2026-01-26WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incec4dbb71-b507-42a3-9b68-14d4b6621ec12026-01-23WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINNCS HealthCare of KY, LLC dba Vangard Labs9105eff0-1c22-4298-8ee5-9fb7a1de12f12026-01-23WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2026-01-22WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC17cfa99d-abb2-4d77-9e0e-e77109fbb61a2026-01-21WarningsExact identifier
application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mgACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MGFarmacias De Similares TX LLC48ea0a2c-511b-4805-e063-6394a90a12252026-01-21WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENMajor Pharmaceuticalsa1b0ccf0-cf24-4b34-b42a-aa1cc1e57f602026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
application number: M013
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc24acd62f-72b1-418a-b733-7e4888f3c0a32026-01-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCardinal Health 110, LLC. DBA Leaderdd8b13a5-07df-4cec-92c3-1a662b1e1a562026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS CO.bdb09e15-8e17-4987-99d0-bab8856a21092026-01-16WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc957b13a4-4086-459f-8fa0-9708b317fabe2026-01-15WarningsExact identifier
application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact 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