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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR1 ML diphenhydrAMINE hydrochloride 50 MG/ML Prefilled Syringe1NAMES
RxNorm Name1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe1NAMES
RxNorm Synonymdiphenhydramine HCl 50 MG per 1 ML Prefilled Syringe1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID6d1aa0e2-036d-4382-a458-fc0300dba7cb1CODES
RxCUI10492891CODES
MMSL_CODEMTH_RXN_BD34181CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 13 matching rows.

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLC6d1aa0e2-036d-4382-a458-fc0300dba7cb2025-04-03Warnings, Adverse reactionsExact identifier
ndc (package): 76045-235-10
ndc (package): 76045-102-10
ndc (product): 76045-235
ndc (product): 76045-102
ndc11 (package): 76045023510
ndc11 (package): 76045010210
ndc11 (package): 76045010200
ndc11 (package): 76045023501
rxcui: 1049289

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
6d1aa0e2-036d-4382-a458-fc0300dba7cbdiphenhydrAMINE HCl 50 MG in 1 ML Prefilled Syringe [PSN] · 1 ML diphenhydramine hydrochloride 50 MG/ML Prefilled Syringe [SCD] · diphenhydramine HCl 50 MG per 1 ML Prefilled Syringe [SY]313DiphenhydrAMINE Hydrochloride Injection, USP20250403

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
6d1aa0e2-036d-4382-a458-fc0300dba7cbDiphenhydrAMINE Hydrochloride Injection, USPFresenius Kabi USA, LLC | Fresenius Kabi, USA LLC20250403
3cfa4719-e616-4aa7-d8a0-98df76177136DiphenhydrAMINE Hydrochloride Injection, USPHospira, Inc.20191120
ed159f2e-1b9a-4259-9b69-d01ebeb1793fDiphenhydramine Hydrochloride 50mg/ml 1mlGeneral Injectables and Vaccines20181106
c199915e-c051-4b4b-988c-58c45e1c550aNational Council for Prescription Drug Programs20130502
e798365d-9ce4-48d3-9c12-c31706accf6dNational 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_STRENGTH50 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY1 ML
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA091526
CODESVUID4002567
NAMESPrescribable SynonymdiphenhydrAMINE HCl 50 MG in 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