FDA.reportPublic FDA data

acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet

RxCUI
1193293
RxNorm name
acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Display name
Acetaminophen/Chlorpheniramine/Phenylephrine (Oral Pill)
Full name
acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Term type
SCD
Status
Active
Strength
325-4-10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-08-01 06:52:42

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122011
Active start
122011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
chlorpheniramine maleate4 MG / 1 EACHchlorpheniraminechlorpheniramine maleate
phenylephrine hydrochloride10 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
chlorpheniramine2400
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI11932931CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
52747-475-7052747-475Norel AD acetaminophen, chlorpheniramine maleate, and phenylephrine HClU.S. PHARMACEUTICAL CORPORATIONM012
63654-601-1063654-601Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideSelder, S.A. de C.V.M012
63654-601-2063654-601Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideSelder, S.A. de C.V.M012
63654-601-5063654-601Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideSelder, S.A. de C.V.M012
76095-010-1076095-010Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideMIDWAY IMPORTING INC.M012
76095-010-2076095-010Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideMIDWAY IMPORTING INC.M012
76095-010-5076095-010Cold Medicine Acetaminophen Chlorpheniramine Maleate Phenylepherine HydrochlorideMIDWAY IMPORTING INC.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01252747-475Norel AD acetaminophen, chlorpheniramine maleate, and phenylephrine HClOTC MONOGRAPH DRUGU.S. PHARMACEUTICAL CORPORATION

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 22 matching rows.

NDC11, Source, Active table
NDC11SourceActive
52747047570rxnav_ndcsyes
63654060101rxnav_ndcsyes
63654060102rxnav_ndcsyes
63654060104rxnav_ndcsyes
63654060110rxnav_ndcsyes
63654060120rxnav_ndcsyes
63654060150rxnav_ndcsyes
76095001001rxnav_ndcsyes
76095001002rxnav_ndcsyes
76095001004rxnav_ndcsyes
76095001010rxnav_ndcsyes
76095001020rxnav_ndcsyes
76095001050rxnav_ndcsyes
58596000201rxnav_historical
58596000202rxnav_historical
58596000204rxnav_historical
58596000210rxnav_historical
58596000220rxnav_historical
58596000250rxnav_historical
63654060002rxnav_historical
63654060068rxnav_historical
72365001208rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norel ADACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCLU.S. PHARMACEUTICAL CORPORATION53d9ed3c-212d-4b12-ac35-8bd49382b49d2025-10-17WarningsExact identifier
ndc (package): 52747-475-70
ndc (product): 52747-475
ndc11 (package): 52747047570
rxcui: 1193293
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.51dd467b-aae8-41fa-e054-00144ff8d46c2024-10-24WarningsExact identifier
ndc (package): 63654-601-20
ndc (package): 63654-601-10
ndc (package): 63654-601-50
ndc (product): 63654-601
ndc11 (package): 63654060150
ndc11 (package): 63654060102
ndc11 (package): 63654060104
ndc11 (package): 63654060101
ndc11 (package): 63654060110
ndc11 (package): 63654060120
rxcui: 1193293
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
ndc (package): 76095-010-10
ndc (package): 76095-010-20
ndc (package): 76095-010-50
ndc (product): 76095-010
ndc11 (package): 76095001020
ndc11 (package): 76095001050
ndc11 (package): 76095001010
ndc11 (package): 76095001004
ndc11 (package): 76095001002
ndc11 (package): 76095001001
rxcui: 1193293

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
53d9ed3c-212d-4b12-ac35-8bd49382b49dacetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD] · APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SY]314Norel® AD20251017
51dd467b-aae8-41fa-e054-00144ff8d46cacetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD] · APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SY]37XL3FrteactmnphnchlrphnirmnphnylphrinhclSldr20241024
58252f15-485c-3061-e053-2a91aa0a2320acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD] · APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SY]37XL3FrteactmnphnchlrphnirmnphnylphrinhclMdway20241017
fc4d100b-eaa9-4e46-a27a-74094aa11d0facetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD] · APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SY]31Drug Facts20111020

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
53d9ed3c-212d-4b12-ac35-8bd49382b49dNorel® ADU.S. PHARMACEUTICAL CORPORATION20251017
51dd467b-aae8-41fa-e054-00144ff8d46cXL3FrteactmnphnchlrphnirmnphnylphrinhclSldrSelder, S.A. de C.V.20241024
58252f15-485c-3061-e053-2a91aa0a2320XL3FrteactmnphnchlrphnirmnphnylphrinhclMdwayMIDWAY IMPORTING INC. | Selder, S.A. de C.V.20241017
53d9ed3c-212d-4b12-ac35-8bd49382b49dNorel® ADU.S. PHARMACEUTICAL CORPORATION20241014
8141a01a-4be7-fc1c-e053-2991aa0a8e4cXL3FrteactmnphnchlrphnirmnphnylphrinhclSlglSelgel México, S.A. de C.V.20201211
68275189-3697-4453-b194-5f6a863a3f5bNational Council for Prescription Drug Programs20120724
fc4d100b-eaa9-4e46-a27a-74094aa11d0fDrug FactsSelder, S.A. de C.V.20111020

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCN02BEAnilidesATC1-4acetaminophen
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR06ABSubstituted alkylaminesATC1-4chlorpheniramine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcchlorpheniramine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine maleate
MEDRTD002744ChlorpheniramineCHEMhas_ingredientchlorpheniramine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine maleate
MEDRTD004342Drug HypersensitivityDISEASEci_withchlorpheniramine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD004380Duodenal ObstructionDISEASEci_withchlorpheniramine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withchlorpheniramine maleate
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine maleate
MEDRTD007231Infant, NewbornDISEASEci_withchlorpheniramine
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine maleate
MEDRTD007234Infant, PrematureDISEASEci_withchlorpheniramine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine
MEDRTD010437Peptic UlcerDISEASEci_withchlorpheniramine maleate
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine
MEDRTD011470Prostatic HyperplasiaDISEASEci_withchlorpheniramine maleate
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatchlorpheniramine maleate
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine maleate
MEDRTD013224Status AsthmaticusDISEASEci_withchlorpheniramine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine maleate
MEDRTD001748Urinary Bladder Neck ObstructionDISEASEci_withchlorpheniramine
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine
MEDRTD014581UrticariaDISEASEmay_treatchlorpheniramine maleate
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moachlorpheniramine maleate
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine maleate
MEDRTN0000008657Decreased Histamine ActivityPEhas_pechlorpheniramine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 4 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymacetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary