FDA.reportPublic FDA data

diphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]

RxCUI
1092466
RxNorm name
diphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]
Display name
SIMPLY SLEEP (Oral Pill)
Full name
diphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]
Term type
SBD
Status
Active
Strength
25 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-24 06:50:22

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 Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRSimply Sleep 25 MG Oral TabletNAMES
RxNorm Namediphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]NAMES
RxNorm SynonymSimply Sleep 25 MG Oral TabletNAMES
TTYSBDATTRIBUTES
SPL_SET_ID37c606b0-04d5-49f0-886a-3ee2c9b0e9ccCODES
RxCUI1092466CODES
MMSL_CODEBD3422CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50580-843-1250580-843Simply Sleep diphenhydramine hydrochlorideKenvue Brands LLCM010

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01050580-843Simply Sleep diphenhydramine hydrochlorideOTC MONOGRAPH DRUGKenvue Brands LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00045084310rxnav_ndcsyes
50580084311rxnav_ndcsyes
50580084312rxnav_ndcsyes
50580084324rxnav_ndcsyes
00045084313rxnav_historical
00045084324rxnav_historical
00045084348rxnav_historical_indirect
00045084372rxnav_historical
00450084310rxnav_historical
50580084310rxnav_historical
50580084313rxnav_historical
50580084325rxnav_historical
50580084348rxnav_historical
50580084372rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
37c606b0-04d5-49f0-886a-3ee2c9b0e9ccdiphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]SBD11Simply Sleep20250602
37c606b0-04d5-49f0-886a-3ee2c9b0e9ccSimply Sleep 25 MG Oral TabletSY11Simply Sleep20250602
37c606b0-04d5-49f0-886a-3ee2c9b0e9ccSimply Sleep 25 MG Oral TabletPSN11Simply Sleep20250602

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
37c606b0-04d5-49f0-886a-3ee2c9b0e9ccSimply SleepKenvue Brands LLC20250602

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
CODESRxCUI1092466
CODESSPL_SET_ID37c606b0-04d5-49f0-886a-3ee2c9b0e9cc
NAMESPrescribable SynonymSimply Sleep 25 MG Oral Tablet
NAMESRXNAV_STRSimply Sleep 25 MG Oral Tablet
NAMESRxNorm Namediphenhydramine hydrochloride 25 MG Oral Tablet [Simply Sleep]
NAMESRxNorm SynonymSimply Sleep 25 MG Oral Tablet
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 25 MG Oral Tablet [Simply Sleep]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon