FDA.reportPublic FDA data

diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]

RxCUI
1092422
RxNorm name
diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]
Display name
BANOPHEN (Oral Pill)
Full name
diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]
Term type
SBD
Status
Active
Strength
25 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-24 06:50:11

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042011
Active start
042011
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 Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRBanophen 25 MG Oral CapsuleNAMES
RxNorm Namediphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]NAMES
RxNorm SynonymBanophen 25 MG Oral CapsuleNAMES
TTYSBDATTRIBUTES
RxCUI1092422CODES
MMSL_CODEBD3404CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0904-7237-240904-7237Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideMajor PharmaceuticalsM012
0904-7237-600904-7237Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideMajor PharmaceuticalsM012
0904-7237-610904-7237Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideMajor PharmaceuticalsM012
0904-7237-800904-7237Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideMajor PharmaceuticalsM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120904-7237Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideOTC MONOGRAPH DRUGMajor Pharmaceuticals

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
00904723724rxnav_ndcsyes
00904723760rxnav_ndcsyes
00904723761rxnav_ndcsyes
00904723780rxnav_ndcsyes
63187077120rxnav_ndcsyes
00904203524rxnav_historical
00904203559rxnav_historical
00904530624rxnav_historical
00904530660rxnav_historical
00904530680rxnav_historical
50090276400rxnav_historical
50090276401rxnav_historical
55700058020rxnav_historical
55700058030rxnav_historical
70253019008rxnav_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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
ndc11 (package): 00904530660
ndc11 (package): 00904530624
ndc11 (package): 00904203524
ndc11 (package): 00904530680
rxcui: 1092422
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
ndc (package): 0904-7237-80
ndc (package): 0904-7237-61
ndc (package): 0904-7237-24
ndc (package): 0904-7237-60
ndc (product): 0904-7237
ndc11 (package): 00904723724
ndc11 (package): 00904723760
ndc11 (package): 00904723761
ndc11 (package): 00904723780

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
04e70311-6412-4a20-84e3-f6e26d5f19abBANOPHEN 25 MG Oral CapsulePSN170835&0836(box unit)-Major20260220
04e70311-6412-4a20-84e3-f6e26d5f19abdiphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]SBD170835&0836(box unit)-Major20260220
04e70311-6412-4a20-84e3-f6e26d5f19abBanophen 25 MG Oral CapsuleSY170835&0836(box unit)-Major20260220

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
04e70311-6412-4a20-84e3-f6e26d5f19ab0835&0836(box unit)-MajorMajor Pharmaceuticals20260220
dca04d80-e781-40b1-e053-2995a90a70100835K- MajorMajor Pharmaceuticals20260220
0219ccba-f597-4e22-933f-f920a07aad6e0835&0836(box unit)-MajorA-S Medication Solutions20240415
278e5b4b-9495-4269-87f2-8897a48ff6f0Diphenhydramine Hydrochloride CapsulesProficient Rx LP20240101
ec1dfb8a-e42d-4c1b-9d0a-20e6ef9468c6Lake Erie Medical DBA Quality Care Products LLC20231221
97fbff25-ec1f-4aa9-8bca-4bcd92912e4bMajor 44-190-DelistedMajor Pharmaceuticals | LNK International, Inc.20171116
0b4a65cc-9c47-45af-bead-889c34a79814National Council for Prescription Drug Programs20130211
555c059d-810d-4ef2-9c17-83fdd1a60d90National Council for Prescription Drug Programs20130211
f29111b7-30ff-4ae3-bc97-b776cde00d6aNational 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_CODEBD3404
CODESRxCUI1092422
NAMESPrescribable SynonymBANOPHEN 25 MG Oral Capsule
NAMESRXNAV_STRBanophen 25 MG Oral Capsule
NAMESRxNorm Namediphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]
NAMESRxNorm SynonymBanophen 25 MG Oral Capsule
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 25 MG Oral Capsule [Banophen]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon