codeine-guaifenesin

Generic: codeine phosphate and guaifenesin

Labeler: method pharmaceuticals, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name codeine-guaifenesin
Generic Name codeine phosphate and guaifenesin
Labeler method pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

codeine phosphate 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Method Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 58657-500
Product ID 58657-500_41b41a1f-2e84-3be6-e063-6294a90a888d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2014-04-01

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 58657500
Hyphenated Format 58657-500

Supplemental Identifiers

RxCUI
995868
UNII
GSL05Y1MN6 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 codeine-guaifenesin (source: ndc)
Generic Name codeine phosphate and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (58657-500-04)
  • 473 mL in 1 BOTTLE (58657-500-16)
source: ndc

Packages (2)

58657-500-04 120 mL in 1 BOTTLE (58657-500-04) 58657-500-16 473 mL in 1 BOTTLE (58657-500-16)

Ingredients (2)

codeine phosphate (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Codeine-Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41b41a1f-2e84-3be6-e063-6294a90a888d", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["GSL05Y1MN6", "495W7451VQ"], "rxcui": ["995868"], "spl_set_id": ["fe126254-6ee6-48c3-965c-96e4276a5314"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Method Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (58657-500-04)", "package_ndc": "58657-500-04", "marketing_start_date": "20140401"}, {"sample": false, "description": "473 mL in 1 BOTTLE (58657-500-16)", "package_ndc": "58657-500-16", "marketing_start_date": "20140401"}], "brand_name": "Codeine-Guaifenesin", "product_id": "58657-500_41b41a1f-2e84-3be6-e063-6294a90a888d", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Full Opioid Agonists [MoA]", "Increased Respiratory Secretions [PE]", "Opioid Agonist [EPC]"], "product_ndc": "58657-500", "dea_schedule": "CIII", "generic_name": "Codeine Phosphate and Guaifenesin", "labeler_name": "Method Pharmaceuticals, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Codeine-Guaifenesin", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140401", "listing_expiration_date": "20261231"}