FDA.reportPublic FDA data

dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet

RxCUI
1363513
RxNorm name
dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Display name
Dexbrompheniramine/Pseudoephedrine (Oral Pill)
Full name
dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
Term type
SCD
Status
Active
Strength
2-60 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-24 06:53:40

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012013
Active start
012013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
dexbrompheniramine maleate2 MG / 1 EACHdexbrompheniraminedexbrompheniramine maleate
pseudoephedrine hydrochloride60 MG / 1 EACHpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
dexbrompheniramine22696
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRdexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletNAMES
RxNorm Namedexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID33d71863-5cac-669f-e063-6394a90a6f21CODES
SPL_SET_ID82f9f52c-797e-4842-9c9a-40213181d99aCODES
SPL_SET_ID847014ab-86ae-40c5-8e7f-f1ddea14f1b3CODES
RxCUI1363513CODES
MMSL_CODEBD27684CODES
MMSL_CODECD27684CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50991-865-0250991-865Durahist Dexbrompheniramine Maleate, Pseudoephedrine HCLPoly Pharmaceuticals, Inc.M012
50991-865-9050991-865Durahist Dexbrompheniramine Maleate, Pseudoephedrine HCLPoly Pharmaceuticals, Inc.M012
54859-702-6054859-702Conex Dexbrompheniramine Maleate, Pseudoephedrine HClLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONM012
63102-401-6063102-401ACTICON DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01250991-865Durahist Dexbrompheniramine Maleate, Pseudoephedrine HCLOTC MONOGRAPH DRUGPoly Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50991086502rxnav_ndcsyes
50991086590rxnav_ndcsyes
54859070260rxnav_ndcsyes
63102040160rxnav_ndcsyes
00085034004rxnav_historical_indirect

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
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
ndc (package): 50991-865-90
ndc (package): 50991-865-02
ndc (product): 50991-865
ndc11 (package): 50991086502
ndc11 (package): 50991086590
rxcui: 1363513
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC847014ab-86ae-40c5-8e7f-f1ddea14f1b32025-07-08WarningsExact identifier
ndc (package): 63102-401-60
ndc (product): 63102-401
ndc11 (package): 63102040160
rxcui: 1363513

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
82f9f52c-797e-4842-9c9a-40213181d99adexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD8Conex Tab Allergy 70220251230
82f9f52c-797e-4842-9c9a-40213181d99adexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN8Conex Tab Allergy 70220251230
847014ab-86ae-40c5-8e7f-f1ddea14f1b3dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN6ACTICON ® COLD & ALLERGY Tablets20250708
847014ab-86ae-40c5-8e7f-f1ddea14f1b3dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD6ACTICON ® COLD & ALLERGY Tablets20250708
33d71863-5cac-669f-e063-6394a90a6f21dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD3Durahist20251230
33d71863-5cac-669f-e063-6394a90a6f21dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN3Durahist20251230

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
82f9f52c-797e-4842-9c9a-40213181d99aConex Tab Allergy 702LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION20251230
33d71863-5cac-669f-e063-6394a90a6f21DurahistPoly Pharmaceuticals, Inc.20251230
847014ab-86ae-40c5-8e7f-f1ddea14f1b3ACTICON ® COLD & ALLERGY TabletsACTIPHARMA, LLC20250708
31e821dd-b951-472b-b0d5-0b8bdce2e125National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06ABSubstituted alkylaminesATC1-4dexbrompheniramine
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine maleate
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine maleate
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine maleate
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine maleate
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH2 MG / 60 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD27684
CODESMMSL_CODECD27684
CODESRxCUI1363513
CODESSPL_SET_ID33d71863-5cac-669f-e063-6394a90a6f21
CODESSPL_SET_ID82f9f52c-797e-4842-9c9a-40213181d99a
CODESSPL_SET_ID847014ab-86ae-40c5-8e7f-f1ddea14f1b3
CODESVUID4006794
NAMESPrescribable Synonymdexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral Tablet
NAMESRXNAV_STRdexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
NAMESRxNorm Namedexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet
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