Home RxNorm 1661314 dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1661314
RxNorm name dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution
Term type SCD
Status Active
Updated 2026-10-20 20:49:48 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 092015
Active start 092015
Multiple ingredient YES
Branded NO Ingredients And Strength# Derived Ingredient Concepts# FDA NDC Products And Packages# Package NDC, Product NDC, Name table Package NDC Product NDC Name Labeler Application 53145-333-15 53145-333 Defensol-ito Dextromethorphan, Guiafenesin, Phenylephrine Menper Distributors, Inc M012
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler M012 53145-333 Defensol-ito Dextromethorphan, Guiafenesin, Phenylephrine OTC MONOGRAPH DRUG Menper Distributors, Inc
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 1 matching rows.
NDC11, Source, Active table NDC11 Source Active 53145033315 rxnav_ndcs yes
UNII Substances# UNII substance links page 1 of 1 · 0 matching rows.
No records found.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective a7c7a60d-d49f-4239-92f7-714eac7eb0c5 dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution [PSN] · dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution [SCD] 2 8 Defensol-ito solution 20250722
Recently Linked DailyMed Labels# Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC C01CA Adrenergic and dopaminergic agents ATC1-4 phenylephrine ATC R05CA Expectorants ATC1-4 guaifenesin ATC R05DA Opium alkaloids and derivatives ATC1-4 dextromethorphan ATC C05AX Other agents for treatment of hemorrhoids and anal fissures for topical use ATC1-4 phenylephrine ATC R01BA Sympathomimetics ATC1-4 phenylephrine ATC S01FB Sympathomimetics excl. antiglaucoma preparations ATC1-4 phenylephrine ATC S01GA Sympathomimetics used as decongestants ATC1-4 phenylephrine ATC R01AB Sympathomimetics, combinations excl. corticosteroids ATC1-4 phenylephrine ATC R01AA Sympathomimetics, plain ATC1-4 phenylephrine FDASPL N0000186105 alpha-1 Adrenergic Agonist EPC has_epc phenylephrine FDASPL N0000193956 Expectorant EPC has_epc guaifenesin FDASPL N0000182149 Sigma-1 Agonist EPC has_epc dextromethorphan FDASPL N0000181821 Uncompetitive N-methyl-D-aspartate Receptor Antagonist EPC has_epc dextromethorphan FDASPL N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan FDASPL N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan MEDRT D003915 Dextromethorphan CHEM has_ingredient dextromethorphan MEDRT D003915 Dextromethorphan CHEM has_ingredient dextromethorphan hydrobromide MEDRT D006140 Guaifenesin CHEM has_ingredient guaifenesin MEDRT D010656 Phenylephrine CHEM has_ingredient phenylephrine hydrochloride MEDRT D010656 Phenylephrine CHEM has_ingredient phenylephrine MEDRT D013447 Sulfites CHEM ci_chemclass phenylephrine MEDRT D013447 Sulfites CHEM ci_chemclass phenylephrine hydrochloride MEDRT D001991 Bronchitis DISEASE may_treat guaifenesin MEDRT D003139 Common Cold DISEASE may_treat guaifenesin MEDRT D003371 Cough DISEASE may_prevent dextromethorphan hydrobromide MEDRT D003371 Cough DISEASE may_treat guaifenesin MEDRT D003371 Cough DISEASE may_treat dextromethorphan MEDRT D003371 Cough DISEASE may_prevent dextromethorphan MEDRT D003371 Cough DISEASE may_treat dextromethorphan hydrobromide MEDRT D004342 Drug Hypersensitivity DISEASE ci_with phenylephrine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with phenylephrine hydrochloride MEDRT D004342 Drug Hypersensitivity DISEASE ci_with dextromethorphan hydrobromide MEDRT D004342 Drug Hypersensitivity DISEASE ci_with guaifenesin MEDRT D004342 Drug Hypersensitivity DISEASE ci_with dextromethorphan MEDRT D005401 Fissure in Ano DISEASE may_treat phenylephrine hydrochloride MEDRT D005401 Fissure in Ano DISEASE may_treat phenylephrine MEDRT D005902 Glaucoma, Open-Angle DISEASE may_treat phenylephrine hydrochloride MEDRT D005902 Glaucoma, Open-Angle DISEASE may_treat phenylephrine MEDRT D006484 Hemorrhoids DISEASE may_treat phenylephrine hydrochloride MEDRT D006484 Hemorrhoids DISEASE may_treat phenylephrine MEDRT D006973 Hypertension DISEASE ci_with phenylephrine MEDRT D006973 Hypertension DISEASE ci_with phenylephrine hydrochloride MEDRT D007022 Hypotension DISEASE may_treat phenylephrine MEDRT D007022 Hypotension DISEASE may_treat phenylephrine hydrochloride MEDRT D007827 Laryngitis DISEASE may_treat guaifenesin MEDRT D015878 Mydriasis DISEASE induces phenylephrine hydrochloride MEDRT D015878 Mydriasis DISEASE induces phenylephrine MEDRT D010612 Pharyngitis DISEASE may_treat guaifenesin MEDRT D011538 Pruritus Ani DISEASE may_treat phenylephrine MEDRT D011538 Pruritus Ani DISEASE may_treat phenylephrine hydrochloride MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat guaifenesin MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat phenylephrine hydrochloride MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat phenylephrine MEDRT D012772 Shock, Septic DISEASE may_treat phenylephrine hydrochloride MEDRT D012772 Shock, Septic DISEASE may_treat phenylephrine MEDRT D012852 Sinusitis DISEASE may_treat guaifenesin MEDRT D013617 Tachycardia, Supraventricular DISEASE may_treat phenylephrine MEDRT D013617 Tachycardia, Supraventricular DISEASE may_treat phenylephrine hydrochloride MEDRT D017180 Tachycardia, Ventricular DISEASE ci_with phenylephrine MEDRT D017180 Tachycardia, Ventricular DISEASE ci_with phenylephrine hydrochloride MEDRT D014917 Whooping Cough DISEASE may_treat guaifenesin MEDRT N0000000209 Adrenergic alpha-Agonists MOA has_moa phenylephrine hydrochloride MEDRT N0000000209 Adrenergic alpha-Agonists MOA has_moa phenylephrine MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa dextromethorphan hydrobromide MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa dextromethorphan MEDRT N0000000109 Serotonin Uptake Inhibitors MOA has_moa dextromethorphan MEDRT N0000000109 Serotonin Uptake Inhibitors MOA has_moa dextromethorphan hydrobromide MEDRT N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan hydrobromide MEDRT N0000182147 Sigma-1 Receptor Agonists MOA has_moa dextromethorphan MEDRT N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan hydrobromide MEDRT N0000181819 Uncompetitive NMDA Receptor Antagonists MOA has_moa dextromethorphan MEDRT N0000008371 Conjunctival Arterial Vasoconstriction PE has_pe phenylephrine MEDRT N0000008371 Conjunctival Arterial Vasoconstriction PE has_pe phenylephrine hydrochloride MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe dextromethorphan hydrobromide MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe dextromethorphan MEDRT N0000008896 Decreased Nasal and Sinus Secretions PE has_pe phenylephrine hydrochloride MEDRT N0000008896 Decreased Nasal and Sinus Secretions PE has_pe phenylephrine MEDRT N0000008867 Decreased Respiratory Secretion Viscosity PE has_pe guaifenesin MEDRT N0000009560 Increased Respiratory Secretions PE has_pe guaifenesin
Properties# Category, Property, Value table Category Property Value ATTRIBUTES ACTIVATED 01/30/2024 ATTRIBUTES ACTIVATED 07/29/2025 ATTRIBUTES ACTIVATED 09/01/2021 ATTRIBUTES AVAILABLE_STRENGTH 4 MG/ML / 50 MG/ML / 2.5 MG/ML ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US NAMES Prescribable Synonym dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution NAMES Tallman Synonym dextromethorphan hydrobromide 4 MG/ML / guaiFENesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution SOURCES Source Metathesaurus FDA Structured Product Labels