FDA.reportPublic FDA data

codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet

RxCUI
1664543
RxNorm name
codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet
Display name
codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet
Full name
codeine phosphate 54.3 MG / chlorpheniramine maleate 8 MG 12HR Oral Extended Release Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TuxarinCODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATEMainpointe Pharmaceuticalsa7cfab67-6087-4ab4-b7cd-4f92954131802024-01-10Boxed warning, Warnings, Adverse reactionsExact 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 IDRxNorm mappingsTermsSPL versionLabelEffective
f3114cff-d638-4562-9e11-88130677363ccodeine 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]37These 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: 198520170120
a7cfab67-6087-4ab4-b7cd-4f9295413180codeine 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]36These 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: 198520240110