FDA.reportPublic FDA data

diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]

RxCUI
1086986
RxNorm name
diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]
Display name
SOMINEX (Oral Pill)
Full name
diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]
Term type
SBD
Status
Active
Strength
25 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-24 06:49:55

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022011
Active start
022011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRSominex 25 MG Oral TabletNAMES
RxNorm Namediphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]NAMES
RxNorm SynonymSominex 25 MG Oral TabletNAMES
TTYSBDATTRIBUTES
SPL_SET_IDf70ce1a6-c334-025e-e053-6294a90ae53fCODES
SPL_SET_IDf7858ecf-8498-4465-85d8-3e7814737573CODES
RxCUI1086986CODES
MMSL_CODEBD3422CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63029-554-0163029-554Sominex DIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.M010
63029-554-1663029-554Sominex DIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.M010
63029-554-3263029-554Sominex DIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.M010
67751-221-0167751-221Sominex DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.M010

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01063029-554Sominex DIPHENHYDRAMINE HYDROCHLORIDEOTC MONOGRAPH DRUGMedtech Products Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 15 matching rows.

NDC11, Source, Active table
NDC11SourceActive
42037010355rxnav_ndcsyes
63029055401rxnav_ndcsyes
63029055416rxnav_ndcsyes
63029055432rxnav_ndcsyes
63029055501rxnav_ndcsyes
63029055516rxnav_ndcsyes
63029055532rxnav_ndcsyes
67751022101rxnav_ndcsyes
00135005707rxnav_historical
00135005711rxnav_historical
00135005716rxnav_historical
53100012822rxnav_historical
53100012832rxnav_historical
53100012851rxnav_historical
67751016901rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
ndc (package): 63029-554-01
ndc (package): 63029-554-32
ndc (package): 63029-554-16
ndc (product): 63029-554
ndc11 (package): 63029055416
ndc11 (package): 63029055432
ndc11 (package): 63029055401
rxcui: 1086986
SominexDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.f70ce1a6-c334-025e-e053-6294a90ae53f2024-10-03WarningsExact identifier
ndc (package): 67751-221-01
ndc (product): 67751-221
ndc11 (package): 67751022101
rxcui: 1086986

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f7858ecf-8498-4465-85d8-3e7814737573diphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]SBD3Sominex-Original20251023
f7858ecf-8498-4465-85d8-3e7814737573Sominex 25 MG Oral TabletSY3Sominex-Original20251023
f7858ecf-8498-4465-85d8-3e7814737573Sominex 25 MG Oral TabletPSN3Sominex-Original20251023
f70ce1a6-c334-025e-e053-6294a90ae53fSominex 25 MG Oral TabletSY2Sominex20241003
f70ce1a6-c334-025e-e053-6294a90ae53fdiphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]SBD2Sominex20241003
f70ce1a6-c334-025e-e053-6294a90ae53fSominex 25 MG Oral TabletPSN2Sominex20241003

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
f7858ecf-8498-4465-85d8-3e7814737573Sominex-OriginalMedtech Products Inc.20251023
f7858ecf-8498-4465-85d8-3e7814737573Sominex-OriginalMedtech Products Inc.20241025
f70ce1a6-c334-025e-e053-6294a90ae53fSominexNavajo Manufacturing Company Inc. | Navajo Manufacturing Company Inc20241003
9e70ead1-479f-48bb-9be4-a8b30b784795Sominex OriginalMedtech Products Inc.20200720
9d2cbdff-2231-4d80-8481-22bcb8385506SominexNavajo Manufacturing Company Inc.20191121
0ad40a70-3a5f-4e6a-9bd4-72e5306cf47dNational Council for Prescription Drug Programs20120724
cee4afc3-96b5-4b14-8b92-fcad1fb9200eNational Council for Prescription Drug Programs20120724
de6b4c1c-eb82-468a-9681-6a6b422864aeNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3422
CODESRxCUI1086986
CODESSPL_SET_IDf70ce1a6-c334-025e-e053-6294a90ae53f
CODESSPL_SET_IDf7858ecf-8498-4465-85d8-3e7814737573
NAMESPrescribable SynonymSominex 25 MG Oral Tablet
NAMESRXNAV_STRSominex 25 MG Oral Tablet
NAMESRxNorm Namediphenhydramine hydrochloride 25 MG Oral Tablet [Sominex]
NAMESRxNorm SynonymSominex 25 MG Oral Tablet
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 25 MG Oral Tablet [Sominex]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon