FDA.reportPublic FDA data

1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe

RxCUI
1049289
RxNorm name
1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe
Display name
diphenhydrAMINE (Injectable)
Full name
1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe
Term type
SCD
Status
Active
Strength
50 mg/ml
Dose form
Prefilled Syringe 1 ml
Route
Injectable
Updated
2026-07-25 06:52:53

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
diphenhydramine hydrochloride50 MG / 1 MLdiphenhydraminediphenhydramine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Prefilled Syringe721656

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STR1 ML diphenhydrAMINE hydrochloride 50 MG/ML Prefilled SyringeNAMES
RxNorm Name1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled SyringeNAMES
RxNorm Synonymdiphenhydramine HCl 50 MG per 1 ML Prefilled SyringeNAMES
TTYSCDATTRIBUTES
SPL_SET_ID6d1aa0e2-036d-4382-a458-fc0300dba7cbCODES
RxCUI1049289CODES
MMSL_CODEMTH_RXN_BD3418CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
76045-102-1076045-102Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideFresenius Kabi USA, LLCANDA091526
76045-235-1076045-235Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideFresenius Kabi USA, LLCANDA091526

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA09152676045-102Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideANDAFresenius Kabi USA, LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
76045010200rxnav_ndcsyes
76045010210rxnav_ndcsyes
76045023501rxnav_ndcsyes
76045023510rxnav_ndcsyes
00071425945rxnav_historical_indirect
00074229001rxnav_historical
00074229031rxnav_historical
00409229003rxnav_historical
00409229011rxnav_historical
00409229031rxnav_historical
00548139000rxnav_historical
52584029031rxnav_historical
55154319308rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
6d1aa0e2-036d-4382-a458-fc0300dba7cb1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled SyringeSCD13DiphenhydrAMINE Hydrochloride Injection, USP20250403
6d1aa0e2-036d-4382-a458-fc0300dba7cbdiphenhydrAMINE HCl 50 MG in 1 ML Prefilled SyringePSN13DiphenhydrAMINE Hydrochloride Injection, USP20250403
6d1aa0e2-036d-4382-a458-fc0300dba7cbdiphenhydramine HCl 50 MG per 1 ML Prefilled SyringeSY13DiphenhydrAMINE Hydrochloride Injection, USP20250403

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
6d1aa0e2-036d-4382-a458-fc0300dba7cbDiphenhydrAMINE Hydrochloride Injection, USPFresenius Kabi USA, LLC | Fresenius Kabi, USA LLC20250403

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_STRENGTH50 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESQUANTITY1 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESANDAANDA091526
CODESMMSL_CODEMTH_RXN_BD3418
CODESRxCUI1049289
CODESSPL_SET_ID6d1aa0e2-036d-4382-a458-fc0300dba7cb
CODESVUID4002567
NAMESPrescribable SynonymdiphenhydrAMINE HCl 50 MG in 1 ML Prefilled Syringe
NAMESRXNAV_STR1 ML diphenhydrAMINE hydrochloride 50 MG/ML Prefilled Syringe
NAMESRxNorm Name1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe
NAMESRxNorm Synonymdiphenhydramine HCl 50 MG per 1 ML Prefilled Syringe
NAMESTallman Synonym1 ML diphenhydrAMINE hydrochloride 50 MG/ML Prefilled Syringe
NAMESTallman SynonymdiphenhydrAMINE HCl 50 MG per 1 ML Prefilled Syringe
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File