Home NDC 58809-217 TexaClear Severe Cough, Cold and Flu
Product NDC 58809-217
11-digit product format 588090217
Labeler code 58809
Product ID 58809-217_4080d923-ca5f-bce0-e063-6294a90a96c2
Type HUMAN OTC DRUG
Nonproprietary name Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-25
Substance CHOLINE SALICYLATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 870; 20; 200 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TexaClear Severe Cough, Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLINE SALICYLATE 870 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL GUAIFENESIN 200 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KD510K1IQW Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58809-217-08 TexaClear Severe Cough, Cold and Flu 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58809-217 TEXACLEAR SEVERE COUGH, COLD AND FLU (CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [GM PHARMACEUTICALS, INC] 2 Current NDC, 1 package rows 20241009_cb99e5b3-1908-43c9-b31f-d35e7ce58b44.zip
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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58809-217-08 58809021708 237 mL in 1 BOTTLE, PLASTIC (58809-217-08) 237 ml 2023-10-25 No No Current