FDA.reportPublic FDA data

acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution

RxCUI
1359455
RxNorm name
acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
Display name
Acetaminophen/Dextromethorphan (Oral Liquid)
Full name
acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
Term type
SCD
Status
Active
Strength
500-15 mg/15ml
Dose form
Sol
Route
Oral Liquid
Updated
2026-07-24 06:52:19

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122012
Active start
032013
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen33.3 MG / 1 MLacetaminophenacetaminophen
dextromethorphan hydrobromide1 MG / 1 MLdextromethorphandextromethorphan hydrobromide

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Solution316968

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
dextromethorphan3289

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionNAMES
RxNorm Nameacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionNAMES
RxNorm Synonymacetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionNAMES
RxNorm Synonymacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionNAMES
RxNorm SynonymAPAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0324195f-506d-4747-990e-ad44e2a117d9CODES
SPL_SET_ID2e9540e4-bd1d-9370-e063-6294a90affcbCODES
SPL_SET_ID326ed27d-cbfa-5513-e063-6394a90a41bfCODES
SPL_SET_ID32bea3dc-9889-22dd-e063-6394a90afa1bCODES
SPL_SET_ID3618ccf0-1f30-42e0-bb50-bfa45cf2b583CODES
SPL_SET_ID52291746-2bbf-8f3f-e063-6294a90adcfcCODES
SPL_SET_IDe5a64d5a-c1ff-453d-b0c1-fe265b9e2c8aCODES
RxCUI1359455CODES
MMSL_CODEBD12804CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0067-8204-010067-8204Theraflu Flu Relief Max Strength Acetaminophen, Dextromethorphan HBrHaleon US Holdings LLCM012
50580-140-0850580-140Extra Strength TYLENOL Severe Cough Plus Sore Throat Day acetaminophen and dextromethorphan hydrobromideKenvue Brands LLCM012
84126-356-0884126-356Vicks DayQuil Acetaminophen, Dextromethorphan HBrThe Procter & Gamble Manufacturing CompanyM012
84126-356-1284126-356Vicks DayQuil Acetaminophen, Dextromethorphan HBrThe Procter & Gamble Manufacturing CompanyM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120067-8204Theraflu Flu Relief Max Strength Acetaminophen, Dextromethorphan HBrOTC MONOGRAPH DRUGHaleon US Holdings LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00067298190rxnav_ndcsyes
00067820401rxnav_ndcsyes
00363069834rxnav_ndcsyes
36800069834rxnav_ndcsyes
50580014008rxnav_ndcsyes
50580021301rxnav_ndcsyes
79481011000rxnav_ndcsyes
84126035608rxnav_ndcsyes
84126035612rxnav_ndcsyes
00113069834rxnav_historical
36800090134rxnav_historical
37808069834rxnav_historical
37808080034rxnav_historical
41250069834rxnav_historical
49348072437rxnav_historical
50580047108rxnav_historical_indirect
55312069834rxnav_historical
55312070034rxnav_historical
61715007608rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0324195f-506d-4747-990e-ad44e2a117d9APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY5Drug Facts20260107
0324195f-506d-4747-990e-ad44e2a117d9acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY5Drug Facts20260107
0324195f-506d-4747-990e-ad44e2a117d9acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD5Drug Facts20260107
0324195f-506d-4747-990e-ad44e2a117d9acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY5Drug Facts20260107
0324195f-506d-4747-990e-ad44e2a117d9acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN5Drug Facts20260107
3618ccf0-1f30-42e0-bb50-bfa45cf2b583APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY4Drug Facts20260326
3618ccf0-1f30-42e0-bb50-bfa45cf2b583acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN4Drug Facts20260326
3618ccf0-1f30-42e0-bb50-bfa45cf2b583acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY4Drug Facts20260326
3618ccf0-1f30-42e0-bb50-bfa45cf2b583acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY4Drug Facts20260326
3618ccf0-1f30-42e0-bb50-bfa45cf2b583acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD4Drug Facts20260326
326ed27d-cbfa-5513-e063-6394a90a41bfAPAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY2Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid20260324
326ed27d-cbfa-5513-e063-6394a90a41bfacetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN2Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid20260324
326ed27d-cbfa-5513-e063-6394a90a41bfacetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY2Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid20260324
326ed27d-cbfa-5513-e063-6394a90a41bfacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD2Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid20260324
326ed27d-cbfa-5513-e063-6394a90a41bfacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY2Vicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM Liquid20260324
32bea3dc-9889-22dd-e063-6394a90afa1bacetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN1Vicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience Pack20250414
32bea3dc-9889-22dd-e063-6394a90afa1bacetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY1Vicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience Pack20250414
32bea3dc-9889-22dd-e063-6394a90afa1bacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD1Vicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience Pack20250414
32bea3dc-9889-22dd-e063-6394a90afa1bAPAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY1Vicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience Pack20250414
32bea3dc-9889-22dd-e063-6394a90afa1bacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY1Vicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience Pack20250414
2e9540e4-bd1d-9370-e063-6294a90affcbacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY1Extra Strength TYLENOL® Severe Cough + Sore Throat Day20250307
2e9540e4-bd1d-9370-e063-6294a90affcbacetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY1Extra Strength TYLENOL® Severe Cough + Sore Throat Day20250307
2e9540e4-bd1d-9370-e063-6294a90affcbacetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN1Extra Strength TYLENOL® Severe Cough + Sore Throat Day20250307
2e9540e4-bd1d-9370-e063-6294a90affcbAPAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY1Extra Strength TYLENOL® Severe Cough + Sore Throat Day20250307
2e9540e4-bd1d-9370-e063-6294a90affcbacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD1Extra Strength TYLENOL® Severe Cough + Sore Throat Day20250307

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
326ed27d-cbfa-5513-e063-6394a90a41bfVicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM LiquidThe Procter & Gamble Manufacturing Company20260622
32bea3dc-9889-22dd-e063-6394a90afa1bVicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience PackThe Procter & Gamble Manufacturing Company20260622
3618ccf0-1f30-42e0-bb50-bfa45cf2b583Drug FactsHaleon US Holdings LLC20260326
326ed27d-cbfa-5513-e063-6394a90a41bfVicks ® DayQuil™ INTENSE FLU MULTI-SYMPTOM LiquidThe Procter & Gamble Manufacturing Company20260324
0324195f-506d-4747-990e-ad44e2a117d9Drug FactsHaleon US Holdings LLC20260107
32bea3dc-9889-22dd-e063-6394a90afa1bVicks ® DayQuil™ and NyQuil™ INTENSE FLU MULTI-SYMPTOM Liquid Convenience PackThe Procter & Gamble Manufacturing Company20250414
2e9540e4-bd1d-9370-e063-6294a90affcbExtra Strength TYLENOL® Severe Cough + Sore Throat DayKenvue Brands LLC20250307

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_STRENGTH33.3 MG/ML / 1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD12804
CODESRxCUI1359455
CODESSPL_SET_ID0324195f-506d-4747-990e-ad44e2a117d9
CODESSPL_SET_ID2e9540e4-bd1d-9370-e063-6294a90affcb
CODESSPL_SET_ID326ed27d-cbfa-5513-e063-6394a90a41bf
CODESSPL_SET_ID32bea3dc-9889-22dd-e063-6394a90afa1b
CODESSPL_SET_ID3618ccf0-1f30-42e0-bb50-bfa45cf2b583
CODESSPL_SET_ID52291746-2bbf-8f3f-e063-6294a90adcfc
CODESSPL_SET_IDe5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a
CODESVUID4043949
NAMESPrescribable Synonymacetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution
NAMESRXNAV_STRacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
NAMESRxNorm Nameacetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
NAMESRxNorm Synonymacetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution
NAMESRxNorm Synonymacetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution
NAMESRxNorm SynonymAPAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File