FDA.reportPublic FDA data

acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension

RxCUI
1370113
RxNorm name
acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
Display name
Acetaminophen/Dextromethorphan (Oral Liquid)
Full name
acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
Term type
SCD
Status
Active
Strength
160-5 mg/5ml
Dose form
Susp
Route
Oral Liquid
Updated
2026-07-26 07:00:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032013
Active start
032013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen32 MG / 1 MLacetaminophenacetaminophen
dextromethorphan hydrobromide1 MG / 1 MLdextromethorphandextromethorphan hydrobromide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Suspension316969

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dextromethorphan3289

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension1NAMES
RxNorm Nameacetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI13701131CODES
MMSL_CODE
4 linked values
4CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0363-6504-040363-6504Walgreen Childrens Acetaminophen and Dextromethorphan HydrobromideWALGREENS CO.M012
50580-194-0150580-194Childrens TYLENOL Acetaminophen and Dextromethorphan HydrobromideKenvue Brands LLCM012
51316-650-0451316-650CVS Childrens Acetaminophen and Dextromethorphan HydrobromideCVS PHARMACYM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120363-6504Walgreen Childrens Acetaminophen and Dextromethorphan HydrobromideOTC MONOGRAPH DRUGWALGREENS CO.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 30 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00363650404rxnav_ndcsyes
50580019401rxnav_ndcsyes
51316065004rxnav_ndcsyes
59779019626rxnav_ndcsyes
00043055404rxnav_historical_indirect
00043621304rxnav_historical_indirect
00043634804rxnav_historical_indirect
00045016904rxnav_historical
00045024705rxnav_historical_indirect
00067051604rxnav_historical_indirect
00067634804rxnav_historical_indirect
00067811504rxnav_historical
00113710126rxnav_historical
00363002904rxnav_historical
00363044244rxnav_historical
11822202301rxnav_historical
24385098626rxnav_historical
30142019626rxnav_historical
36800089326rxnav_historical
42507002326rxnav_historical
42507019626rxnav_historical
44237004303rxnav_historical
50428477062rxnav_historical_indirect
50428706409rxnav_historical
50580024704rxnav_historical_indirect
50580247049rxnav_historical_indirect
52183035504rxnav_historical_indirect
55312019626rxnav_historical
63941012404rxnav_historical_indirect
69842062226rxnav_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
CVS Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY27820bce-6638-4f17-ac66-62b02b76bec32025-12-09WarningsExact identifier
ndc (package): 51316-650-04
ndc (product): 51316-650
ndc11 (package): 51316065004
rxcui: 1370113
Walgreen Childrens COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.801880b2-6116-4d26-a7bf-a669eef6ad8b2025-11-26WarningsExact identifier
ndc (package): 0363-6504-04
ndc (product): 0363-6504
ndc11 (package): 00363650404
rxcui: 1370113
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
ndc (package): 50580-194-01
ndc (product): 50580-194
ndc11 (package): 50580019401
rxcui: 1370113

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
e83f7911-22b4-4ffc-8f49-68f6acd2ebf5acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension [PSN] · acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension [SCD] · acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension [SY] · APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension [SY] · APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension [SY]56Children's TYLENOL ® COLD + COUGH + SORE THROAT20241107
801880b2-6116-4d26-a7bf-a669eef6ad8bacetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension [PSN] · acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension [SCD] · acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension [SY] · APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension [SY] · APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension [SY]54Walgreens Children's Cold + Cough + Sore Throat Relief20251126
27820bce-6638-4f17-ac66-62b02b76bec3acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension [PSN] · acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension [SCD] · acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension [SY] · APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension [SY] · APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension [SY]53Children's Cold + Cough + Sore Throat Relief20251209

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
27820bce-6638-4f17-ac66-62b02b76bec3Children's Cold + Cough + Sore Throat ReliefCVS PHARMACY20251209
801880b2-6116-4d26-a7bf-a669eef6ad8bWalgreens Children's Cold + Cough + Sore Throat ReliefWALGREENS CO.20251126
e83f7911-22b4-4ffc-8f49-68f6acd2ebf5Children's TYLENOL ® COLD + COUGH + SORE THROATKenvue Brands LLC20241107
7f631f45-06e4-4860-abb7-1e1b1e146035Herbion Pakistan (Pvt.) Ltd20200321
467a8f31-c0bc-4a87-a0f0-dcc50c9a7c2fTopco Associates LLC. Children’s Cold, Cough & Sore Throat Drug FactsTopco Associates LLC20200218
8276b3ee-08e6-49f0-abfc-27cecad604caRite Aid Corporation Children’s Pain Relief Cold & Cough & Sore Throat Drug FactsRite Aid Corporation20190805
b2fd492d-bec6-4a6f-993f-98e33a348c75CVS Pharmacy, Inc. Children’s Cough & Sore Throat Drug FactsCVS Pharmacy20190226
600696d0-d111-44b6-9ab4-68f4d99af195Amazon Children’s Cold, & Cough & Sore Throat Drug FactsL. Perrigo Company20190211
11b12b82-e7a8-4fb0-9139-29d9dad84470Drug FactsWalgreens20181228
06818312-c8ca-4047-b5d4-9dd38c18dfe1CVS Pharmacy, Inc. Cough & Sore Throat Drug FactsCVS Pharmacy20181212
26667462-edf2-4201-9a32-f51b0ca9df7fNational Council for Prescription Drug Programs20130213
3bb4c6f2-1310-400b-88bb-f872170bbea5National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCR05DAOpium alkaloids and derivativesATC1-4dextromethorphan
FDASPLN0000182149Sigma-1 AgonistEPChas_epcdextromethorphan
FDASPLN0000181821Uncompetitive N-methyl-D-aspartate Receptor AntagonistEPChas_epcdextromethorphan
FDASPLN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
FDASPLN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan hydrobromide
MEDRTD003915DextromethorphanCHEMhas_ingredientdextromethorphan
MEDRTD003371CoughDISEASEmay_treatdextromethorphan hydrobromide
MEDRTD003371CoughDISEASEmay_treatdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan
MEDRTD003371CoughDISEASEmay_preventdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan hydrobromide
MEDRTD004342Drug HypersensitivityDISEASEci_withdextromethorphan
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan hydrobromide
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moadextromethorphan
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000000109Serotonin Uptake InhibitorsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan
MEDRTN0000182147Sigma-1 Receptor AgonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan hydrobromide
MEDRTN0000181819Uncompetitive NMDA Receptor AntagonistsMOAhas_moadextromethorphan
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pedextromethorphan hydrobromide
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_STRENGTH32 MG/ML / 1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4037657
NAMESPrescribable Synonymacetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
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