texaclear severe cough, cold and flu

Generic: choline salicylate, dextromethorphan hydrobromide, guaifenesin

Labeler: gm pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name texaclear severe cough, cold and flu
Generic Name choline salicylate, dextromethorphan hydrobromide, guaifenesin
Labeler gm pharmaceuticals, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

choline salicylate 870 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 200 mg/30mL

Manufacturer
GM Pharmaceuticals, INC

Identifiers & Regulatory

Product NDC 58809-217
Product ID 58809-217_4080d923-ca5f-bce0-e063-6294a90a96c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58809217
Hyphenated Format 58809-217

Supplemental Identifiers

RxCUI
2670541
UPC
0358809217083
UNII
KD510K1IQW 9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name texaclear severe cough, cold and flu (source: ndc)
Generic Name choline salicylate, dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 870 mg/30mL
  • 20 mg/30mL
  • 200 mg/30mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (58809-217-08)
source: ndc

Packages (1)

58809-217-08 237 mL in 1 BOTTLE, PLASTIC (58809-217-08)

Ingredients (3)

choline salicylate (870 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (200 mg/30mL)

Linked Drug Pages (1)

TexaClear Severe Cough, Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4080d923-ca5f-bce0-e063-6294a90a96c2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0358809217083"], "unii": ["KD510K1IQW", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2670541"], "spl_set_id": ["cb99e5b3-1908-43c9-b31f-d35e7ce58b44"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GM Pharmaceuticals, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (58809-217-08)", "package_ndc": "58809-217-08", "marketing_start_date": "20231025"}], "brand_name": "TexaClear Severe Cough, Cold and Flu", "product_id": "58809-217_4080d923-ca5f-bce0-e063-6294a90a96c2", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "58809-217", "generic_name": "Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin", "labeler_name": "GM Pharmaceuticals, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TexaClear Severe Cough, Cold and Flu", "active_ingredients": [{"name": "CHOLINE SALICYLATE", "strength": "870 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}