FDA.reportPublic FDA data

diphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]

RxCUI
1093113
RxNorm name
diphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]
Display name
UNISOM SLEEP (Oral Pill)
Full name
diphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]
Term type
SBD
Status
Active
Strength
50 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-22 07:07:20

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 hydrochloride50 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_STRUnisom Sleep 50 MG Oral CapsuleNAMES
RxNorm Namediphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]NAMES
RxNorm SynonymUnisom Sleep 50 MG Oral CapsuleNAMES
RxNorm SynonymUnisom Sleepgels Maximum Strength 50 MG Oral CapsuleNAMES
TTYSBDATTRIBUTES
SPL_SET_ID17383d22-91cc-4d9e-a0b8-3f7d9a18af83CODES
RxCUI1093113CODES
MMSL_CODEBD3406CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
41167-0061-041167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010
41167-0061-141167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010
41167-0061-241167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010
41167-0061-341167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010
41167-0061-541167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010
41167-0061-641167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClChattem, Inc.M010

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01041167-0061Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HClOTC MONOGRAPH DRUGChattem, Inc.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
41157000611rxnav_ndcsyes
41167000133rxnav_ndcsyes
41167000610rxnav_ndcsyes
41167000611rxnav_ndcsyes
41167000613rxnav_ndcsyes
41167000616rxnav_ndcsyes
41167001303rxnav_ndcsyes
41167006100rxnav_ndcsyes
41167006101rxnav_ndcsyes
41167006102rxnav_ndcsyes
41167006103rxnav_ndcsyes
41167006105rxnav_ndcsyes
41167006106rxnav_ndcsyes
74300000133rxnav_ndcsyes
00501600008rxnav_historical
00501600016rxnav_historical
00501600032rxnav_historical
41167013302rxnav_historical
74300000610rxnav_historical
74300000611rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
17383d22-91cc-4d9e-a0b8-3f7d9a18af83Unisom Sleepgels Maximum Strength 50 MG Oral CapsuleSY9Unisom SleepGels Nighttime20260114
17383d22-91cc-4d9e-a0b8-3f7d9a18af83Unisom SleepGels 50 MG Oral CapsulePSN9Unisom SleepGels Nighttime20260114
17383d22-91cc-4d9e-a0b8-3f7d9a18af83Unisom Sleep 50 MG Oral CapsuleSY9Unisom SleepGels Nighttime20260114
17383d22-91cc-4d9e-a0b8-3f7d9a18af83diphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]SBD9Unisom SleepGels Nighttime20260114

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
17383d22-91cc-4d9e-a0b8-3f7d9a18af83Unisom SleepGels NighttimeChattem, Inc.20260114

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
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3406
CODESRxCUI1093113
CODESSPL_SET_ID17383d22-91cc-4d9e-a0b8-3f7d9a18af83
NAMESPrescribable SynonymUnisom SleepGels 50 MG Oral Capsule
NAMESRXNAV_STRUnisom Sleep 50 MG Oral Capsule
NAMESRxNorm Namediphenhydramine hydrochloride 50 MG Oral Capsule [Unisom Sleep]
NAMESRxNorm SynonymUnisom Sleep 50 MG Oral Capsule
NAMESRxNorm SynonymUnisom Sleepgels Maximum Strength 50 MG Oral Capsule
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 50 MG Oral Capsule [Unisom Sleep]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon