FDA.reportPublic FDA data

doxylamine succinate 25 MG Oral Tablet [Unisom]

RxCUI
1101448
RxNorm name
doxylamine succinate 25 MG Oral Tablet [Unisom]
Display name
UNISOM (Oral Pill)
Full name
doxylamine succinate 25 MG Oral Tablet [Unisom]
Term type
SBD
Status
Active
Strength
25 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-20 20:47:49

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
062011
Active start
062011
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
doxylamine succinate25 MG / 1 EACHdoxylaminedoxylamine succinate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
doxylamine3642

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRUnisom 25 MG Oral Tablet1NAMES
RxNorm Namedoxylamine succinate 25 MG Oral Tablet [Unisom]1NAMES
RxNorm SynonymUnisom 25 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI11014481CODES
MMSL_CODEBD56151CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
41167-0063-541167-0063Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040167
41167-0063-641167-0063Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040167
41167-0063-741167-0063Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040167
41167-0063-841167-0063Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040167
41167-0608-041167-0608Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040564
41167-0608-141167-0608Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040564
41167-0608-241167-0608Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040564
41167-0608-341167-0608Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040564
41167-0608-441167-0608Unisom SleepTabs Doxylamine SuccinateChattem, Inc.ANDA040564

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA04016741167-0063Unisom SleepTabs Doxylamine SuccinateANDAChattem, Inc.
ANDA04056441167-0608Unisom SleepTabs Doxylamine SuccinateANDAChattem, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 29 matching rows.

NDC11, Source, Active table
NDC11SourceActive
41167000607rxnav_ndcsyes
41167000609rxnav_ndcsyes
41167000623rxnav_ndcsyes
41167006305rxnav_ndcsyes
41167006306rxnav_ndcsyes
41167006307rxnav_ndcsyes
41167006308rxnav_ndcsyes
41167060800rxnav_ndcsyes
41167060801rxnav_ndcsyes
41167060802rxnav_ndcsyes
41167060803rxnav_ndcsyes
41167060804rxnav_ndcsyes
00501600108rxnav_historical
00501600116rxnav_historical
00501600132rxnav_historical
00501600148rxnav_historical
41167000603rxnav_historical
41167000606rxnav_historical
41167006002rxnav_historical
41167006003rxnav_historical
41167006006rxnav_historical
41167006007rxnav_historical
41167006009rxnav_historical
41167006203rxnav_historical
54868488200rxnav_historical
74300000606rxnav_historical
74300000607rxnav_historical
74300000609rxnav_historical
74300000623rxnav_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
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.7ae32d74-76a0-47e2-9e5c-812426413c4e2026-03-25WarningsExact identifier
ndc (package): 41167-0608-3
ndc (package): 41167-0608-2
ndc (package): 41167-0608-0
ndc (package): 41167-0608-1
ndc (package): 41167-0608-4
ndc (product): 41167-0608
ndc11 (package): 41167060803
ndc11 (package): 41167060800
ndc11 (package): 41167060804
ndc11 (package): 41167060801
ndc11 (package): 41167060802
rxcui: 1101448
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.f591d52f-5610-4517-a96f-1ed63deb00bc2026-01-14WarningsExact identifier
ndc (package): 41167-0063-8
ndc (package): 41167-0063-6
ndc (package): 41167-0063-7
ndc (package): 41167-0063-5
ndc (product): 41167-0063
ndc11 (package): 41167006308
ndc11 (package): 41167006306
ndc11 (package): 41167006307
ndc11 (package): 41167006305
rxcui: 1101448

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f591d52f-5610-4517-a96f-1ed63deb00bcUnisom SleepTabs 25 MG Oral Tablet [PSN] · doxylamine succinate 25 MG Oral Tablet [Unisom] [SBD] · Unisom 25 MG Oral Tablet [SY]35Unisom SleepTabs20260114
7ae32d74-76a0-47e2-9e5c-812426413c4eUnisom SleepTabs 25 MG Oral Tablet [PSN] · doxylamine succinate 25 MG Oral Tablet [Unisom] [SBD] · Unisom 25 MG Oral Tablet [SY]31Unisom Sleep Tabs-220260325

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
7ae32d74-76a0-47e2-9e5c-812426413c4eUnisom Sleep Tabs-2Chattem, Inc.20260325
f591d52f-5610-4517-a96f-1ed63deb00bcUnisom SleepTabsChattem, Inc.20260114
d5e3015c-49ae-4288-a78f-17a141f26817Unisom SleepTabsChattem, Inc.19781018

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AAAminoalkyl ethersATC1-4doxylamine
FDASPLN0000175750AntihistamineEPChas_epcdoxylamine
FDASPLN0000000207Histamine Receptor AntagonistsMOAhas_moadoxylamine
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine succinate
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine succinate
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine succinate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine succinate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine succinate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine succinate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine succinate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG (expressed as doxylamine succinate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA040167
CODESANDAANDA040564
NAMESPrescribable SynonymUnisom SleepTabs 25 MG Oral Tablet
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon