FDA.reportPublic FDA data

LOW DOSE ASPIRIN

Product NDC
71335-1382
11-digit product format
713351382
Labeler code
71335
Product ID
71335-1382_bc4654ca-a310-4862-bb6f-c56b34f3a86e
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-19
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
LOW DOSE ASPIRIN
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
a272bf44-54df-448a-8bff-e31f9488b416Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1382-1LOW DOSE ASPIRIN120 in 1 BOTTLETABLET, COATED1205
71335-1382-2LOW DOSE ASPIRIN30 in 1 BOTTLETABLET, COATED305
71335-1382-3LOW DOSE ASPIRIN100 in 1 BOTTLETABLET, COATED1005
71335-1382-4LOW DOSE ASPIRIN20 in 1 BOTTLETABLET, COATED205
71335-1382-5LOW DOSE ASPIRIN90 in 1 BOTTLETABLET, COATED905
71335-1382-6LOW DOSE ASPIRIN60 in 1 BOTTLETABLET, COATED605
71335-1382-7LOW DOSE ASPIRIN36 in 1 BOTTLETABLET, COATED365
71335-1382-8LOW DOSE ASPIRIN15 in 1 BOTTLETABLET, COATED155
71335-1382-9LOW DOSE ASPIRIN10 in 1 BOTTLETABLET, COATED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1382-2EA - Each71335-138260bcd795-8c37-4aa2-ae53-ac8a3508219812021-03-02
71335-1382-3EA - Each71335-1382c43a24a3-2686-436c-86c6-d5155bcbc9c512025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1382LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20240507_a272bf44-54df-448a-8bff-e31f9488b416.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 4 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNa272bf44-54df-448a-8bff-e31f9488b4165
308416aspirin 81 MG Delayed Release Oral TabletSCDa272bf44-54df-448a-8bff-e31f9488b4165
308416ASA 81 MG Delayed Release Oral TabletSYa272bf44-54df-448a-8bff-e31f9488b4165
308416aspirin 81 MG Enteric Coated Oral TabletSYa272bf44-54df-448a-8bff-e31f9488b4165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1382-171335138201120 TABLET, COATED in 1 BOTTLE (71335-1382-1) 2021-01-040000-00-00NoNoCurrent
71335-1382-27133513820230 TABLET, COATED in 1 BOTTLE (71335-1382-2) 2020-03-120000-00-00NoNoCurrent
71335-1382-371335138203100 TABLET, COATED in 1 BOTTLE (71335-1382-3) 2021-01-210000-00-00NoNoCurrent
71335-1382-47133513820420 TABLET, COATED in 1 BOTTLE (71335-1382-4) 2020-12-180000-00-00NoNoCurrent
71335-1382-57133513820590 TABLET, COATED in 1 BOTTLE (71335-1382-5) 2021-03-150000-00-00NoNoCurrent
71335-1382-67133513820660 TABLET, COATED in 1 BOTTLE (71335-1382-6) 2022-03-100000-00-00NoNoCurrent
71335-1382-77133513820736 TABLET, COATED in 1 BOTTLE (71335-1382-7) 2020-12-310000-00-00NoNoCurrent
71335-1382-87133513820815 TABLET, COATED in 1 BOTTLE (71335-1382-8) 2021-01-060000-00-00NoNoCurrent
71335-1382-97133513820910 TABLET, COATED in 1 BOTTLE (71335-1382-9) 2022-03-100000-00-00NoNoCurrent