FDA.reportPublic FDA data

Aspirin 81 mg

Product NDC
69618-066
11-digit product format
696180066
Labeler code
69618
Product ID
69618-066_2bc86823-a7dc-875d-e063-6394a90a992a
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
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

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 81 mg
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
b247fe39-7f65-e502-e053-2a95a90a08f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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, Related label table
NDCEffectiveRelated label
69618-066-022023-03-29Aspirin 81mg EC
69618-066-102023-03-29Aspirin 81mg EC
69618-066-022023-01-30Aspirin 81mg EC
69618-066-102023-01-30Aspirin 81mg EC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-066-02Aspirin 81 mg120 in 1 BOTTLE, PLASTICTABLET, COATED1208
69618-066-10Aspirin 81 mg1000 in 1 BOTTLE, PLASTICTABLET, COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-066-02EA - Each69618-06662b9ed73-35e0-48f9-8353-be8d0065dad012021-06-02
69618-066-10EA - Each69618-066ed5bac14-7d3d-4c3b-942e-399a7565711512021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-066ASPIRIN 81 MG (ASPIRIN) TABLET, COATED [RELIABLE 1 LABORATORIES LLC]8Current NDC, Legacy NDC, 2 package rows20250117_b247fe39-7f65-e502-e053-2a95a90a08f1.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNcce1e8bd-63c8-403a-bc32-e6788493f604104
308416aspirin 81 MG Delayed Release Oral TabletSCDcce1e8bd-63c8-403a-bc32-e6788493f604104
308416ASA 81 MG Delayed Release Oral TabletSYcce1e8bd-63c8-403a-bc32-e6788493f604104
308416aspirin 81 MG Enteric Coated Oral TabletSYcce1e8bd-63c8-403a-bc32-e6788493f604104
308416aspirin 81 MG Delayed Release Oral TabletPSNb247fe39-7f65-e502-e053-2a95a90a08f18
308416aspirin 81 MG Delayed Release Oral TabletSCDb247fe39-7f65-e502-e053-2a95a90a08f18
308416ASA 81 MG Delayed Release Oral TabletSYb247fe39-7f65-e502-e053-2a95a90a08f18
308416aspirin 81 MG Enteric Coated Oral TabletSYb247fe39-7f65-e502-e053-2a95a90a08f18
308416aspirin 81 MG Delayed Release Oral TabletPSN878dab20-668b-4d7a-a5f8-794a587564d53
308416aspirin 81 MG Delayed Release Oral TabletSCD878dab20-668b-4d7a-a5f8-794a587564d53
308416ASA 81 MG Delayed Release Oral TabletSY878dab20-668b-4d7a-a5f8-794a587564d53
308416aspirin 81 MG Enteric Coated Oral TabletSY878dab20-668b-4d7a-a5f8-794a587564d53
308416aspirin 81 MG Delayed Release Oral TabletPSN19489806-f99d-472c-a3c8-2d4561c9a44d1
308416aspirin 81 MG Delayed Release Oral TabletPSNac7f11d2-cbfd-4610-a652-fc2f1ea41d7e1
308416aspirin 81 MG Delayed Release Oral TabletSCD19489806-f99d-472c-a3c8-2d4561c9a44d1
308416aspirin 81 MG Delayed Release Oral TabletSCDac7f11d2-cbfd-4610-a652-fc2f1ea41d7e1
308416ASA 81 MG Delayed Release Oral TabletSYac7f11d2-cbfd-4610-a652-fc2f1ea41d7e1
308416ASA 81 MG Delayed Release Oral TabletSY19489806-f99d-472c-a3c8-2d4561c9a44d1
308416aspirin 81 MG Enteric Coated Oral TabletSYac7f11d2-cbfd-4610-a652-fc2f1ea41d7e1
308416aspirin 81 MG Enteric Coated Oral TabletSY19489806-f99d-472c-a3c8-2d4561c9a44d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-066-0269618006602120 TABLET, COATED in 1 BOTTLE, PLASTIC (69618-066-02) 2020-10-010000-00-00NoNoCurrent
69618-066-10696180066101000 TABLET, COATED in 1 BOTTLE, PLASTIC (69618-066-10) 2020-10-010000-00-00NoNoCurrent