FDA.reportPublic FDA data

ASPIRIN

Product NDC
69168-318
11-digit product format
691680318
Labeler code
69168
Product ID
69168-318_2899105f-ce56-4f8f-8966-0f18aed41d75
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
2014-12-18
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct69168-318IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69168-31869168-318-03IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69168-31869168-318-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
5910a882-eb40-440f-8a30-c21fbce9050eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69168-318-012023-10-19Bio Formula Aspirin 81mg
69168-318-032023-10-19Bio Formula Aspirin 81mg
69168-318-012023-01-30Bio Formula Aspirin 81mg
69168-318-032023-01-30Bio Formula Aspirin 81mg
69168-318-012020-12-03Bio Formula Aspirin 81mg
69168-318-032020-12-03Bio Formula Aspirin 81mg
69168-318-012020-01-31Bio Formula Aspirin 81mg
69168-318-032020-01-31Bio Formula Aspirin 81mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-318-06AspirinEnteric Coated120 in 1 BOTTLETABLET1209
69168-318-06AspirinEnteric Coated1 in 1 CARTONTABLET19
69168-318-17AspirinEnteric Coated300 in 1 BOTTLETABLET3009
69168-318-50AspirinEnteric Coated1 in 1 CARTONTABLET19
69168-318-50AspirinEnteric Coated50 in 1 BOTTLETABLET509
69168-318-01ASPIRINEnteric Coated1 in 1 CARTONTABLET16
69168-318-01ASPIRINEnteric Coated100 in 1 BOTTLETABLET1006
69168-318-03ASPIRINEnteric Coated300 in 1 BOTTLETABLET3006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-318ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]9Current NDC, Legacy NDC, 5 package rows20231114_3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5.zip
69168-318ASPIRIN ENTERIC COATED (ASPIRIN 81 MG) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 3 package rows20231020_5910a882-eb40-440f-8a30-c21fbce9050e.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 24 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menstrual Relief Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEUnited Natural Foods, Inc. dba UNFI807598ef-9f03-48df-b076-3ee95ef4b06c2026-01-05WarningsExact identifier
application number: M013
Pain Relief Extra Strength, Non-AspirinACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1fb5e871-45fd-46fe-bf73-5192f8316e8e2026-01-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENValu Merchandisers Company0005aafa-08f8-4990-a54d-cc097195708f2026-01-02WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENWalmart Inc.152bb455-da5b-ae13-e063-6394a90acab02026-01-01WarningsExact identifier
application number: M013
Dr. Cocoa for Children Pain and FeverACETAMINOPHENInfirst Healthcare Inc.486ea294-6d18-a907-e063-6294a90ad2842026-01-01WarningsExact identifier
application number: M013
ED APAPACETAMINOPHENEDWARDS PHARMACEUTICALS, INC.f76d5fff-ebea-40f9-aad3-4064a0c863f02025-12-31WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENGERI-CARE PHARMACEUTICAL CORP99ec63ef-aa28-c2fb-e053-2a95a90a9f6d2025-12-31WarningsExact identifier
application number: M013
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
application number: M013
Liquid AcetaminophenACETAMINOPHENLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONa7dbd4c0-53eb-4368-917b-1432c09ce6b42025-12-31WarningsExact identifier
application number: M013
Llorens Care Children AcetaminophenACETAMINOPHENLlorens Pharmaceutical International Division, Inc.2a46d7d2-293b-5024-e063-6294a90a31aa2025-12-31WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)Walgreens3a801457-c5d0-b134-e063-6294a90ac5cb2025-12-31WarningsExact identifier
application number: M013
Daytime and Nighttime Severe Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEGenexa Inc.190c7eaf-dcd4-d314-e063-6294a90a6f332025-12-30WarningsExact identifier
application number: M013
BioElectro Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEGenomma Lab USA683a0fba-921c-48e7-a391-180c04f0d1c42025-12-30WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLC0181af13-da32-4431-be39-c31fdfac92022025-12-29WarningsExact identifier
application number: M013
Gemma Cut the CrampASPIRIN, CAFFEINERally Labs LLC16c9a296-077a-8e12-e063-6294a90a1b8b2025-12-29WarningsExact identifier
application number: M013
BlowfishASPIRIN, CAFFEINERally Labs LLC0d3798bc-04ef-584e-821b-7aa76036b7d12025-12-29WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEPioneer Life Sciences, LLCac9efd62-8fee-b777-e053-2995a90a37832025-12-29WarningsExact identifier
application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
application number: M013
Cystex PMACETAMINOPHEN, DIPHENHYDRAMINE HCLClarion Brands, LLC9668a2ca-729e-4172-80b5-33e6c5175ba42025-12-27WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe59
308416aspirin 81 MG Delayed Release Oral TabletSCD3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe59
308416ASA 81 MG Delayed Release Oral TabletSY3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe59
308416aspirin 81 MG Enteric Coated Oral TabletSY3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe59
308416aspirin 81 MG Delayed Release Oral TabletPSN5910a882-eb40-440f-8a30-c21fbce9050e6
308416aspirin 81 MG Delayed Release Oral TabletSCD5910a882-eb40-440f-8a30-c21fbce9050e6
308416ASA 81 MG Delayed Release Oral TabletSY5910a882-eb40-440f-8a30-c21fbce9050e6
308416aspirin 81 MG Enteric Coated Oral TabletSY5910a882-eb40-440f-8a30-c21fbce9050e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-318-01691680318011 BOTTLE in 1 CARTON (69168-318-01) / 100 TABLET in 1 BOTTLE1 bottle2014-12-180000-00-00NoNoCurrent
69168-318-0369168031803300 TABLET in 1 BOTTLE (69168-318-03) 300 tablet2014-12-180000-00-00NoNoCurrent
69168-318-06691680318061 BOTTLE in 1 CARTON (69168-318-06) / 120 TABLET in 1 BOTTLE1 bottle2014-12-180000-00-00NoNoCurrent
69168-318-1769168031817300 TABLET in 1 BOTTLE (69168-318-17) 300 tablet2014-12-180000-00-00NoNoCurrent
69168-318-50691680318501 BOTTLE in 1 CARTON (69168-318-50) / 50 TABLET in 1 BOTTLE1 bottle2014-12-180000-00-00NoNoCurrent