FDA.reportPublic FDA data

chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution

RxCUI
1551286
RxNorm name
chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution
Display name
Chlophedianol/Dexbrompheniramine (Oral Liquid)
Full name
chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
12.5-1 mg/5ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-10-13 14:25:28

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112014
Active start
112014
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlophedianol hydrochloride2.5 MG / 1 MLchlophedianolchlophedianol hydrochloride
dexbrompheniramine maleate0.2 MG / 1 MLdexbrompheniraminedexbrompheniramine maleate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
chlophedianol21254
dexbrompheniramine22696

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRchlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution1NAMES
RxNorm Namechlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution1NAMES
RxNorm Synonymchlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_IDd046f4ba-5753-4ed5-a924-0b66fd1167811CODES
RxCUI15512861CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
12830-864-0412830-864Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine MaleateR. A. McNeil CompanyM012
12830-864-1612830-864Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine MaleateR. A. McNeil CompanyM012
12830-864-2012830-864Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine MaleateR. A. McNeil CompanyM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01212830-864Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine MaleateOTC MONOGRAPH DRUGR. A. McNeil Company

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
12830086404rxnav_ndcsyes
12830086416rxnav_ndcsyes
12830086420rxnav_ndcsyes
50090399800rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlo HistCHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATER. A. McNeil Companyd046f4ba-5753-4ed5-a924-0b66fd1167812025-10-15WarningsExact identifier
ndc (package): 12830-864-16
ndc (package): 12830-864-04
ndc (package): 12830-864-20
ndc (product): 12830-864
ndc11 (package): 12830086420
ndc11 (package): 12830086416
ndc11 (package): 12830086404
rxcui: 1551286

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
d046f4ba-5753-4ed5-a924-0b66fd116781chlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral Solution [PSN] · chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution [SCD] · chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution [SY]313Chlo Hist Oral Solution20251015
bca1807a-6040-4001-bce4-57c48e647dedchlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral Solution [PSN] · chlophedianol hydrochloride 2.5 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution [SCD] · chlophedianol hydrochloride 12.5 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution [SY]31Chlo Hist Oral Solution20190116

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
d046f4ba-5753-4ed5-a924-0b66fd116781Chlo Hist Oral SolutionR. A. McNeil Company20251015
d046f4ba-5753-4ed5-a924-0b66fd116781Chlo Hist Oral SolutionR. A. McNeil Company20240315
bca1807a-6040-4001-bce4-57c48e647dedChlo Hist Oral SolutionA-S Medication Solutions20190116

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05DBOther cough suppressantsATC1-4chlophedianol
ATCR06ABSubstituted alkylaminesATC1-4dexbrompheniramine
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine
MEDRTD001977BrompheniramineCHEMhas_ingredientdexbrompheniramine maleate
MEDRTD011412PropanolaminesCHEMhas_ingredientchlophedianol
MEDRTD011412PropanolaminesCHEMhas_ingredientchlophedianol hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine
MEDRTD003139Common ColdDISEASEmay_treatdexbrompheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdexbrompheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine maleate
MEDRTD012852SinusitisDISEASEmay_treatdexbrompheniramine
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatdexbrompheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadexbrompheniramine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedexbrompheniramine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH2.5 MG/ML (expressed as chlophedianol hydrochloride) / 0.2 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymchlophedianol HCl 12.5 MG / dexbrompheniramine maleate 1 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