FDA.reportPublic FDA data

chlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution

RxCUI
1053618
RxNorm name
chlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
Display name
Chlorpheniramine/Pseudoephedrine (Oral Liquid)
Full name
chlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
2-30 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-08-01 06:52:14

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022011
Active start
022011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlorpheniramine maleate0.4 MG / 1 MLchlorpheniraminechlorpheniramine maleate
pseudoephedrine hydrochloride6 MG / 1 MLpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
chlorpheniramine2400
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRchlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution1NAMES
RxNorm Namechlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution1NAMES
RxNorm Synonymchlorpheniramine maleate 2 MG / psuedoephedrine hydrochloride 30 MG per 5 ML Syrup1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID93c9ad4f-3376-48c2-8276-0375663acd011CODES
RxCUI10536181CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
68047-120-1668047-120LoHist Chlorpheniramine Maleate / Pseudoephedrine HClLarken Laboratories, Inc.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01268047-120LoHist Chlorpheniramine Maleate / Pseudoephedrine HClOTC MONOGRAPH DRUGLarken Laboratories, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 56 matching rows.

NDC11, Source, Active table
NDC11SourceActive
68047012016rxnav_ndcsyes
00037063866rxnav_historical_indirect
00037063868rxnav_historical_indirect
00081087182rxnav_historical_indirect
00091005204rxnav_historical_indirect
00235226401rxnav_historical_indirect
00259223501rxnav_historical_indirect
00259223504rxnav_historical_indirect
00259223516rxnav_historical_indirect
00259223530rxnav_historical_indirect
00295018516rxnav_historical_indirect
00295018599rxnav_historical_indirect
00372003801rxnav_historical_indirect
00372003804rxnav_historical_indirect
00372003808rxnav_historical_indirect
00372003816rxnav_historical_indirect
00482018512rxnav_historical_indirect
00482018516rxnav_historical_indirect
00482018599rxnav_historical_indirect
00527084327rxnav_historical_indirect
00527084328rxnav_historical_indirect
00538397816rxnav_historical_indirect
00551027516rxnav_historical_indirect
00551027599rxnav_historical_indirect
00585226101rxnav_historical_indirect
00585226199rxnav_historical_indirect
00642009104rxnav_historical_indirect
00832859604rxnav_historical_indirect
00904560616rxnav_historical_indirect
23589000216rxnav_historical_indirect
23900000607rxnav_historical_indirect
43797007614rxnav_historical_indirect
43797007616rxnav_historical_indirect
50419018516rxnav_historical_indirect
50419018571rxnav_historical_indirect
50732087504rxnav_historical_indirect
51301098215rxnav_historical_indirect
51301098216rxnav_historical_indirect
51301098230rxnav_historical_indirect
51655070756rxnav_historical_indirect
51674000401rxnav_historical_indirect
51674000407rxnav_historical_indirect
51991022616rxnav_historical_indirect
52349041016rxnav_historical_indirect
52349041030rxnav_historical_indirect
55654004016rxnav_historical
58298046016rxnav_historical_indirect
58298046020rxnav_historical_indirect
59010012516rxnav_historical_indirect
62022027515rxnav_historical_indirect
62022027516rxnav_historical_indirect
62022027599rxnav_historical_indirect
62542052404rxnav_historical_indirect
64376071416rxnav_historical
67336027515rxnav_historical_indirect
67336027516rxnav_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
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
rxcui: 1053618
LoHist DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.93c9ad4f-3376-48c2-8276-0375663acd012026-07-16WarningsExact identifier
ndc (package): 68047-120-16
ndc (product): 68047-120
ndc11 (package): 68047012016
rxcui: 1053618

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
93c9ad4f-3376-48c2-8276-0375663acd01chlorpheniramine maleate 2 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution [PSN] · chlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution [SCD] · chlorpheniramine maleate 2 MG / psuedoephedrine hydrochloride 30 MG per 5 ML Syrup [SY]311LoHist D20251015

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
93c9ad4f-3376-48c2-8276-0375663acd01LoHist DLarken Laboratories, Inc.20260716
93c9ad4f-3376-48c2-8276-0375663acd01LoHist DLarken Laboratories, Inc.20251015
93c9ad4f-3376-48c2-8276-0375663acd01LoHist DLarken Laboratories, Inc.20241010
bade0cf9-7697-4f43-80bf-ae9cd5dd830cNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06ABSubstituted alkylaminesATC1-4chlorpheniramine
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcchlorpheniramine
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine maleate
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine maleate
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.4 MG/ML / 6 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4005381
CODESVUID4005383
NAMESPrescribable Synonymchlorpheniramine maleate 2 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary