Home RxNorm 1659175 acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for 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 1659175
RxNorm name acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Display name Acetaminophen/diphenhydrAMINE/Phenylephrine (Oral Solution Powder)
Full name acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
Term type SCD
Status Active
Strength 500-25-10 mg
Dose form Pwdr
Route Oral Solution Powder
Updated 2026-10-20 20:48:54 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 0067-6801-02 0067-6801 Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Haleon US Holdings LLC M012
Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler M012 0067-6801 Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride OTC MONOGRAPH DRUG Haleon US Holdings LLC
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.
NDC11, Source, Active table NDC11 Source Active 00067680102 rxnav_ndcs yes 00067812401 rxnav_ndcs yes 00067812406 rxnav_ndcs yes 69842070091 rxnav_historical
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 0d3b1bea-e2ca-4e07-8ae5-60627d230c96 acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral Solution [PSN] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution [SCD] · acetaminophen 500 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral [SY] · acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution [SY] · APAP 500 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution [SY] 5 2 Drug Facts 20240308
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 R06AA Aminoalkyl ethers ATC1-4 diphenhydramine ATC N02BE Anilides ATC1-4 acetaminophen ATC D04AA Antihistamines for topical use ATC1-4 diphenhydramine 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 N0000175587 Histamine-1 Receptor Antagonist EPC has_epc diphenhydramine FDASPL N0000000190 Histamine H1 Receptor Antagonists MOA has_moa diphenhydramine MEDRT D000082 Acetaminophen CHEM has_ingredient acetaminophen MEDRT D004155 Diphenhydramine CHEM has_ingredient diphenhydramine hydrochloride MEDRT D004155 Diphenhydramine CHEM has_ingredient diphenhydramine MEDRT D010656 Phenylephrine CHEM has_ingredient phenylephrine MEDRT D010656 Phenylephrine CHEM has_ingredient phenylephrine hydrochloride MEDRT D013447 Sulfites CHEM ci_chemclass phenylephrine MEDRT D013447 Sulfites CHEM ci_chemclass phenylephrine hydrochloride MEDRT D001008 Anxiety Disorders DISEASE may_treat diphenhydramine hydrochloride MEDRT D001008 Anxiety Disorders DISEASE may_treat diphenhydramine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with diphenhydramine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with diphenhydramine hydrochloride MEDRT D004342 Drug Hypersensitivity DISEASE ci_with phenylephrine hydrochloride MEDRT D004342 Drug Hypersensitivity DISEASE ci_with acetaminophen MEDRT D004342 Drug Hypersensitivity DISEASE ci_with phenylephrine MEDRT D005334 Fever DISEASE may_treat acetaminophen MEDRT D005334 Fever DISEASE may_prevent acetaminophen MEDRT D005401 Fissure in Ano DISEASE may_treat phenylephrine MEDRT D005401 Fissure in Ano DISEASE may_treat phenylephrine hydrochloride MEDRT D005902 Glaucoma, Open-Angle DISEASE may_treat phenylephrine hydrochloride MEDRT D005902 Glaucoma, Open-Angle DISEASE may_treat phenylephrine MEDRT D005955 Glucosephosphate Dehydrogenase Deficiency DISEASE ci_with acetaminophen 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 hydrochloride MEDRT D007022 Hypotension DISEASE may_treat phenylephrine MEDRT D007231 Infant, Newborn DISEASE ci_with diphenhydramine hydrochloride MEDRT D007231 Infant, Newborn DISEASE ci_with diphenhydramine MEDRT D007234 Infant, Premature DISEASE ci_with diphenhydramine hydrochloride MEDRT D007234 Infant, Premature DISEASE ci_with diphenhydramine MEDRT D007774 Lactation DISEASE ci_with diphenhydramine MEDRT D007774 Lactation DISEASE ci_with diphenhydramine hydrochloride MEDRT D008107 Liver Diseases DISEASE ci_with acetaminophen MEDRT D009041 Motion Sickness DISEASE may_treat diphenhydramine hydrochloride MEDRT D009041 Motion Sickness DISEASE may_treat diphenhydramine MEDRT D015878 Mydriasis DISEASE induces phenylephrine MEDRT D015878 Mydriasis DISEASE induces phenylephrine hydrochloride MEDRT D009325 Nausea DISEASE may_treat diphenhydramine hydrochloride MEDRT D009325 Nausea DISEASE may_treat diphenhydramine MEDRT D010146 Pain DISEASE may_treat acetaminophen MEDRT D010146 Pain DISEASE may_prevent acetaminophen 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 diphenhydramine MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat diphenhydramine hydrochloride MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat phenylephrine MEDRT D012223 Rhinitis, Vasomotor DISEASE may_treat phenylephrine hydrochloride MEDRT D012772 Shock, Septic DISEASE may_treat phenylephrine hydrochloride MEDRT D012772 Shock, Septic DISEASE may_treat phenylephrine MEDRT D007319 Sleep Initiation and Maintenance Disorders DISEASE may_treat diphenhydramine hydrochloride MEDRT D007319 Sleep Initiation and Maintenance Disorders DISEASE may_treat diphenhydramine MEDRT D012912 Sneezing DISEASE may_treat diphenhydramine MEDRT D012912 Sneezing DISEASE may_treat diphenhydramine hydrochloride MEDRT D013224 Status Asthmaticus DISEASE ci_with diphenhydramine MEDRT D013224 Status Asthmaticus DISEASE ci_with diphenhydramine hydrochloride 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 hydrochloride MEDRT D017180 Tachycardia, Ventricular DISEASE ci_with phenylephrine MEDRT D014581 Urticaria DISEASE may_treat diphenhydramine MEDRT D014581 Urticaria DISEASE may_treat diphenhydramine hydrochloride MEDRT N0000000209 Adrenergic alpha-Agonists MOA has_moa phenylephrine MEDRT N0000000209 Adrenergic alpha-Agonists MOA has_moa phenylephrine hydrochloride MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa diphenhydramine hydrochloride MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa diphenhydramine MEDRT N0000000108 Prostaglandin Receptor Antagonists MOA has_moa acetaminophen MEDRT N0000175724 Central Nervous System Activity Alteration PE has_pe acetaminophen MEDRT N0000008371 Conjunctival Arterial Vasoconstriction PE has_pe phenylephrine MEDRT N0000008371 Conjunctival Arterial Vasoconstriction PE has_pe phenylephrine hydrochloride MEDRT N0000008896 Decreased Nasal and Sinus Secretions PE has_pe phenylephrine hydrochloride MEDRT N0000008896 Decreased Nasal and Sinus Secretions PE has_pe phenylephrine MEDRT N0000008836 Decreased Prostaglandin Production PE has_pe acetaminophen MEDRT N0000009072 Hypothalamic Endocrine Activity Alteration PE has_pe acetaminophen MEDRT N0000175725 Peripheral Nervous System Activity Alteration PE has_pe acetaminophen MEDRT N0000000026 Hepatic Metabolism PK has_pk acetaminophen MEDRT N0000000042 Renal Excretion PK has_pk acetaminophen
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 500 MG / 25 MG / 10 MG ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 NAMES Prescribable Synonym acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Powder for Oral Solution NAMES Tallman Synonym acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral NAMES Tallman Synonym acetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution NAMES Tallman Synonym acetaminophen 500 MG / diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution NAMES Tallman Synonym APAP 500 MG / diphenhydrAMINE Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon