Home RxNorm 1664543 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet 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 1664543
RxNorm name 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet
Display name Chlorpheniramine/Codeine XR (Oral Pill)
Full name 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet
Term type SCD
Status Active
Strength 8-54.3 mg
Dose form 12 HR XR Tab
Route Oral Pill
Updated 2026-10-20 20:50:37 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 102015
Active start 102015
Multiple ingredient YES
Branded NO
Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength chlorpheniramine maleate 8 MG / 1 EACH chlorpheniramine chlorpheniramine maleate codeine phosphate 54.3 MG / 1 EACH codeine codeine phosphate
Derived Ingredient Concepts# 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 00722718401 rxnav_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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tuxarin CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE Mainpointe Pharmaceuticals a7cfab67-6087-4ab4-b7cd-4f9295413180 2024-01-10 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 1664543
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 · 2 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective f3114cff-d638-4562-9e11-88130677363c codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet [PSN] · 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet [SCD] · chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG 12HR Oral Extended Release Tablet [SY] 3 7 These highlights do not include all the information needed to use CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE™ safely and effectively. See full prescribing information for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (codeine phosphate and chlorpheniramine maleate) extended release tablets, CIII Initial U.S. Approval: 1985 20170120 a7cfab67-6087-4ab4-b7cd-4f9295413180 codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet [PSN] · 12 HR chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG Extended Release Oral Tablet [SCD] · chlorpheniramine maleate 8 MG / codeine phosphate 54.3 MG 12HR Oral Extended Release Tablet [SY] 3 6 These highlights do not include all the information needed to use TUXARIN ER™ safely and effectively. See full prescribing information for TUXARIN ER. TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, for oral use, CIII Initial U.S. Approval: 1985 20240110
Recently Linked DailyMed Labels# Set ID, Title, Manufacturer table Set ID Title Manufacturer Effective f3114cff-d638-4562-9e11-88130677363c These highlights do not include all the information needed to use CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE™ safely and effectively. See full prescribing information for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE (codeine phosphate and chlorpheniramine maleate) extended release tablets, CIII Initial U.S. Approval: 1985 Nexgen Pharma, Inc. | Spiraso LLC 20170120
Drug Classes# Source, Class ID, Class table Source Class ID Class Type Relationship Drug concept ATC R05DA Opium alkaloids and derivatives ATC1-4 codeine ATC R06AB Substituted alkylamines ATC1-4 chlorpheniramine FDASPL N0000175587 Histamine-1 Receptor Antagonist EPC has_epc chlorpheniramine MEDRT D002744 Chlorpheniramine CHEM has_ingredient chlorpheniramine maleate MEDRT D002744 Chlorpheniramine CHEM has_ingredient chlorpheniramine MEDRT D003061 Codeine CHEM has_ingredient codeine phosphate MEDRT D003061 Codeine CHEM has_ingredient codeine MEDRT D009020 Morphine CHEM has_active_metabolites codeine phosphate MEDRT D009020 Morphine CHEM has_active_metabolites codeine MEDRT D001249 Asthma DISEASE ci_with codeine phosphate MEDRT D001249 Asthma DISEASE ci_with codeine MEDRT D003371 Cough DISEASE may_treat codeine MEDRT D003371 Cough DISEASE may_treat codeine phosphate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with codeine phosphate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with chlorpheniramine MEDRT D004342 Drug Hypersensitivity DISEASE ci_with chlorpheniramine maleate MEDRT D004342 Drug Hypersensitivity DISEASE ci_with codeine MEDRT D004380 Duodenal Obstruction DISEASE ci_with chlorpheniramine MEDRT D004380 Duodenal Obstruction DISEASE ci_with chlorpheniramine maleate MEDRT D015812 Glaucoma, Angle-Closure DISEASE ci_with chlorpheniramine MEDRT D015812 Glaucoma, Angle-Closure DISEASE ci_with chlorpheniramine maleate MEDRT D007231 Infant, Newborn DISEASE ci_with chlorpheniramine MEDRT D007231 Infant, Newborn DISEASE ci_with chlorpheniramine maleate MEDRT D007234 Infant, Premature DISEASE ci_with chlorpheniramine MEDRT D007234 Infant, Premature DISEASE ci_with chlorpheniramine maleate MEDRT D007415 Intestinal Obstruction DISEASE ci_with codeine phosphate MEDRT D007415 Intestinal Obstruction DISEASE ci_with codeine MEDRT D010146 Pain DISEASE may_treat codeine phosphate MEDRT D010146 Pain DISEASE may_treat codeine MEDRT D010437 Peptic Ulcer DISEASE ci_with chlorpheniramine MEDRT D010437 Peptic Ulcer DISEASE ci_with chlorpheniramine maleate MEDRT D011247 Pregnancy DISEASE ci_with codeine phosphate MEDRT D011247 Pregnancy DISEASE ci_with codeine MEDRT D011470 Prostatic Hyperplasia DISEASE ci_with chlorpheniramine maleate MEDRT D011470 Prostatic Hyperplasia DISEASE ci_with chlorpheniramine MEDRT D012131 Respiratory Insufficiency DISEASE ci_with codeine MEDRT D012131 Respiratory Insufficiency DISEASE ci_with codeine phosphate MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat chlorpheniramine maleate MEDRT D012221 Rhinitis, Allergic, Perennial DISEASE may_treat chlorpheniramine MEDRT D013224 Status Asthmaticus DISEASE ci_with chlorpheniramine maleate MEDRT D013224 Status Asthmaticus DISEASE ci_with chlorpheniramine MEDRT D001748 Urinary Bladder Neck Obstruction DISEASE ci_with chlorpheniramine MEDRT D001748 Urinary Bladder Neck Obstruction DISEASE ci_with chlorpheniramine maleate MEDRT D014581 Urticaria DISEASE may_treat chlorpheniramine maleate MEDRT D014581 Urticaria DISEASE may_treat chlorpheniramine MEDRT N0000175684 Full Opioid Agonists MOA has_moa codeine phosphate MEDRT N0000175684 Full Opioid Agonists MOA has_moa codeine MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa chlorpheniramine maleate MEDRT N0000000190 Histamine H1 Receptor Antagonists MOA has_moa chlorpheniramine MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa codeine phosphate MEDRT N0000000184 Monoamine Oxidase Inhibitors MOA ci_moa codeine MEDRT N0000175439 Analgesia PE has_pe codeine MEDRT N0000175439 Analgesia PE has_pe codeine phosphate MEDRT N0000008657 Decreased Histamine Activity PE has_pe chlorpheniramine MEDRT N0000008657 Decreased Histamine Activity PE has_pe chlorpheniramine maleate MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe codeine MEDRT N0000008701 Decreased Medullary Respiratory Drive PE has_pe codeine phosphate MEDRT N0000008768 Decreased Organized Electrical Activity PE has_pe codeine phosphate MEDRT N0000008768 Decreased Organized Electrical Activity PE has_pe codeine MEDRT N0000000026 Hepatic Metabolism PK has_pk codeine MEDRT N0000000026 Hepatic Metabolism PK site_of_metabolism codeine MEDRT N0000000026 Hepatic Metabolism PK has_pk codeine phosphate MEDRT N0000000026 Hepatic Metabolism PK site_of_metabolism codeine phosphate MEDRT N0000000042 Renal Excretion PK has_pk codeine MEDRT N0000000042 Renal Excretion PK has_pk codeine phosphate
Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 8 MG / 54.3 MG ATTRIBUTES GENERAL_CARDINALITY MULTI ATTRIBUTES HUMAN_DRUG US ATTRIBUTES QUANTITY 12 HR ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 3 CODES VUID 4038200 NAMES Prescribable Synonym codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon SOURCES Source National Drug Data File Plus Source Vocabulary SOURCES Source Veterans Health Administration National Drug File