FDA.reportPublic FDA data

acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral

RxCUI
1659175
RxNorm name
acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral
Display name
acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral
Full name
acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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 NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC0d3b1bea-e2ca-4e07-8ae5-60627d230c962024-03-08WarningsExact identifier
rxcui: 1659175

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
0d3b1bea-e2ca-4e07-8ae5-60627d230c96acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral [SY] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 500 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY]52Drug Facts20240308