FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
71399-1014
11-digit product format
713991014
Labeler code
71399
Product ID
71399-1014_4f21474d-3cc3-11b6-e063-6294a90a38b8
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
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
2027-12-31
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
2027-12-31

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
e9b1cf21-b0a3-43b6-9ea6-3df62c0e43edAvailable 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
71399-1014-1Low Dose Aspirin1000 in 1 BOTTLETABLET, COATED10004
71399-1014-2Low Dose Aspirin120 in 1 BOTTLETABLET, COATED1204
71399-1014-4Low Dose Aspirin400000 in 1 DRUMTABLET, COATED4000004
71399-1014-5Low Dose Aspirin100000 in 1 DRUMTABLET, COATED1000004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1014-1EA - Each71399-10147f0a97c0-2386-40aa-b15f-ce50131597b212025-05-14
71399-1014-2EA - Each71399-10141595f099-e7f0-4e11-87e9-0cde623e0ffb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1014LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [AKRON PHAMA]2Current NDC, 4 package rows20250511_e9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed.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 46 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINBryant Ranch Prepack9d0449d2-c0c6-4e74-931b-35dc625840282025-03-31WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINBryant Ranch Prepackcce1e8bd-63c8-403a-bc32-e6788493f6042025-03-31WarningsExact identifier
application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
application number: M013
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
application number: M013
CounterAct PainACETAMINOPHENMelaleuca, Inc.7faf76b4-7f25-377d-e053-2a91aa0a19d42025-03-20Boxed warning, WarningsExact identifier
application number: M013
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
application number: M013
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
application number: M013
Signature Select Effervescent Pain ReliefASPIRINSafeway Inc.304fca65-2867-c963-e063-6394a90a183f2025-03-14WarningsExact identifier
application number: M013
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNe9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed4
308416aspirin 81 MG Delayed Release Oral TabletSCDe9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed4
308416ASA 81 MG Delayed Release Oral TabletSYe9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed4
308416aspirin 81 MG Enteric Coated Oral TabletSYe9b1cf21-b0a3-43b6-9ea6-3df62c0e43ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71399-1014-1713991014011000 TABLET, COATED in 1 BOTTLE (71399-1014-1) 2024-12-06NoNoCurrent
71399-1014-271399101402120 TABLET, COATED in 1 BOTTLE (71399-1014-2) 2024-12-06NoNoCurrent
71399-1014-471399101404400000 TABLET, COATED in 1 DRUM (71399-1014-4) 2024-12-06NoNoCurrent
71399-1014-571399101405100000 TABLET, COATED in 1 DRUM (71399-1014-5) 2024-12-06NoNoCurrent