FDA.reportPublic FDA data

Adult Low Dose Chewable Aspirin

Product NDC
85786-110
11-digit product format
857860110
Labeler code
85786
Product ID
85786-110_5a6e1c4f-c2ca-521f-e063-6394a90af574
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Farmacias De Similares TX LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-01
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
Adult Low Dose Chewable 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
318272Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
513ea306-74c6-96e3-e063-6394a90a8262Available on FDA.report

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 26 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Incc4f82ed8-b82c-47bb-9ab9-108a13d29cf72025-12-22WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc5103450a-3095-49cc-9823-4fb4c1d258ff2025-12-22WarningsExact identifier
application number: M013
CAREALL Non-Aspirin PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc499b2bf8-72fb-4500-b16e-517cab09a8ae2025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc933154b9-c9d6-4260-8775-1c83631c74e42025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
application number: M013
AspirinASPIRINL.N.K. International, Inc.35005045-57b2-4ffe-ab70-22d570c1b1612025-12-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalmart175495fd-c561-f813-e063-6294a90aac802025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f57305-0c4b-96b1-e063-6394a90a77df2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLPUBLIX SUPERMARKETS, INC08f549cf-042a-7bf2-e063-6394a90a83ef2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b8a855ae-c0a3-0b05-e053-2a95a90ac8a82025-12-19WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMarc Glassman, Inc.f708e1ec-cf2a-4e2b-851f-f6b703f359b22025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b375de90-25c7-aa55-e053-2995a90a3cf82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTARGET CORPORATIONe64a3c32-5466-0662-e053-2a95a90ae9632025-12-19WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85786-110-368578601103636 TABLET, CHEWABLE in 1 BOTTLE (85786-110-36) 2026-09-01NoNoCurrent