FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
68196-481
11-digit product format
681960481
Labeler code
68196
Product ID
68196-481_5bbeafb9-9892-3ce9-e063-6394a90a8c8b
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
SAM'S WEST INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
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
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

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
68196-481-70Low Dose Aspirin2 in 1 CARTONTABLET, COATED22
68196-481-70Low Dose Aspirin365 in 1 BOTTLETABLET, COATED3652

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-481LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [SAM'S WEST INC]2Current NDC, 2 package rows20240701_16595d62-8507-103c-e063-6394a90a491a.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 77 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINEProficient Rx LPaf8b30a0-7a56-4557-8404-cc8059fcd6bc2023-11-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAMERIFOODS TRADING COMPANYf6dd387d-c768-9443-e053-6394a90aca142023-10-31WarningsExact identifier
application number: M013
ASPIRINASPIRINAMERIFOODS TRADING COMPANYf6cec280-17a5-5c5d-e053-6394a90a81aa2023-10-31WarningsExact identifier
application number: M013
Regular Strength AspirinASPIRINCARDINAL HEALTH, INC.8aaa82c6-b46b-25c5-e053-2a95a90a37932023-10-30WarningsExact identifier
application number: M013
SafeTynadolACETAMINOPHENSinew Pharma Inc.b956d527-7ea7-e084-e053-2a95a90a866d2023-10-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMagno-Humphries, Inc.9d2275c8-0c3d-d2b3-e053-2995a90a368e2023-10-27WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENMagno-Humphries, Inc.9d22bedb-9fb3-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENMagno-Humphries, Inc.9d22d642-8aaf-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M013
ENTERIC COATED ASPIRINASPIRINMagno-Humphries, Inc.a7c02378-4213-4e57-aca2-2437ad02f7862023-10-27WarningsExact identifier
application number: M013
ExtraprinACETAMINOPHEN, ASPIRIN, CAFFEINEMagno-Humphries, Inc.9d22cdc8-29c5-4273-e053-2a95a90ad0bf2023-10-27WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINGeri-Care Pharmaceutical Corpc321208c-f192-42c5-9454-e0df5d02d6852023-10-26WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN16595d62-8507-103c-e063-6394a90a491a2
308416aspirin 81 MG Delayed Release Oral TabletSCD16595d62-8507-103c-e063-6394a90a491a2
308416ASA 81 MG Delayed Release Oral TabletSY16595d62-8507-103c-e063-6394a90a491a2
308416aspirin 81 MG Enteric Coated Oral TabletSY16595d62-8507-103c-e063-6394a90a491a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-481-70681960481702 BOTTLE in 1 CARTON (68196-481-70) / 365 TABLET, COATED in 1 BOTTLE (68196-481-36) 2 bottle2024-07-01NoNoCurrent