FDA.reportPublic FDA data

12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet

RxCUI
1363288
RxNorm name
12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet
Display name
Chlorpheniramine XR (Oral Pill)
Full name
12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet
Term type
SCD
Status
Active
Strength
12 mg
Dose form
12 HR XR Tab
Route
Oral Pill
Updated
2026-08-01 06:56:05

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
chlorpheniramine maleate12 MG / 1 EACHchlorpheniraminechlorpheniramine maleate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
chlorpheniramine2400

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet1NAMES
RxNorm Name12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet1NAMES
RxNorm Synonymchlorpheniramine maleate 12 MG 12 HR Extended Release Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI13632881CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
10702-017-0110702-017Chlorphen-12 Chlorpheniramine MaleateKVK-Tech, Inc.ANDA040829
10702-017-0610702-017Chlorphen-12 Chlorpheniramine MaleateKVK-Tech, Inc.ANDA040829
10702-017-2410702-017Chlorphen-12 Chlorpheniramine MaleateKVK-Tech, Inc.ANDA040829
10702-017-5410702-017Chlorphen-12 Chlorpheniramine MaleateKVK-Tech, Inc.ANDA040829
69842-017-2469842-017Allergy Relief Chlorpheniramine MaleateCVS PharmacyANDA040829

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA04082910702-017Chlorphen-12 Chlorpheniramine MaleateANDAKVK-Tech, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

NDC11, Source, Active table
NDC11SourceActive
10702001701rxnav_ndcsyes
10702001704rxnav_ndcsyes
10702001706rxnav_ndcsyes
10702001724rxnav_ndcsyes
10702001754rxnav_ndcsyes
37205011762rxnav_ndcsyes
58809036301rxnav_ndcsyes
69842001724rxnav_ndcsyes
10207001706rxnav_historical
50428832002rxnav_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
Chlorphen-12CHLORPHENIRAMINE MALEATEKVK-Tech, Inc.84409269-fe9b-469e-9a66-27b1475231a32018-12-19WarningsExact identifier
ndc (package): 10702-017-54
ndc (package): 10702-017-06
ndc (package): 10702-017-24
ndc (package): 10702-017-01
ndc (product): 10702-017
ndc11 (package): 10702001701
ndc11 (package): 10702001706
ndc11 (package): 10702001704
ndc11 (package): 10702001724
ndc11 (package): 10702001754
rxcui: 1363288
Allergy ReliefCHLORPHENIRAMINE MALEATECVS Pharmacy626aa162-f5e3-45c0-b5ac-d70bff255aed2017-01-19WarningsExact identifier
ndc (package): 69842-017-24
ndc (product): 69842-017
ndc11 (package): 69842001724
rxcui: 1363288

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
84409269-fe9b-469e-9a66-27b1475231a3chlorpheniramine maleate 12 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet [SCD] · chlorpheniramine maleate 12 MG 12 HR Extended Release Oral Tablet [SY]34Chlorphen-12 (Chlorpheniramine Maleate) Extended-Release Tablets, 12 mg20181219
626aa162-f5e3-45c0-b5ac-d70bff255aedchlorpheniramine maleate 12 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet [SCD] · chlorpheniramine maleate 12 MG 12 HR Extended Release Oral Tablet [SY]31CVS Pharmacy, Inc. Allergy Relief Drug Facts20170119

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
84409269-fe9b-469e-9a66-27b1475231a3Chlorphen-12 (Chlorpheniramine Maleate) Extended-Release Tablets, 12 mgKVK-Tech, Inc. | Avanthi, Inc.20181219
626aa162-f5e3-45c0-b5ac-d70bff255aedCVS Pharmacy, Inc. Allergy Relief Drug FactsCVS Pharmacy20170119
88273ebc-e706-4a95-8da1-91eb4ffe9cd6National Council for Prescription Drug Programs20130213
f305b502-0c47-4323-8289-8c165c899940National Council for Prescription Drug Programs20130213
cade2f27-fc17-4538-bcdc-67bafd85371dUnknown TitleCardinal Health, Inc. | KVK-Tech, Inc.20120830

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06ABSubstituted alkylaminesATC1-4chlorpheniramine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcchlorpheniramine
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine maleate
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine maleate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine maleate
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine maleate
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH12 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY12 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA040829
CODESVUID4002547
NAMESPrescribable Synonymchlorpheniramine maleate 12 MG 12HR Extended Release 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