FDA.reportPublic FDA data

acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet

RxCUI
2691689
RxNorm name
acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet
Display name
acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet
Full name
acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
rxcui: 2691689

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6ba64bbe-7599-406a-9187-737c0f8c1c2aacetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Chewable Tablet [PSN] · acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet [SCD] · APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet [SY]32Drug Facts20240905