guaifenesin and codeine phosphate (0121-0775)

Drug Facts

Product Profile

Brand Name guaifenesin and codeine phosphate

Generic Name guaifenesin and codeine phosphate

Labeler pai holdings, llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

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

Manufacturer

PAI Holdings, LLC

Identifiers & Regulatory

Product NDC 0121-0775

Product ID 0121-0775_2175415b-f07e-50a6-e063-6394a90acabe

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

DEA Schedule cv

Listing Expiration 2026-12-31

Marketing Start 2006-10-01

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 01210775

Hyphenated Format 0121-0775

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 guaifenesin and codeine phosphate (source: ndc)

Generic Name guaifenesin and codeine phosphate (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/5mL
100 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (0121-0775-04)
473 mL in 1 BOTTLE (0121-0775-16)

source: ndc

Packages (2)

0121-0775-04 118 mL in 1 BOTTLE (0121-0775-04) 0121-0775-16 473 mL in 1 BOTTLE (0121-0775-16)

Ingredients (2)

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

Linked Drug Pages (1)

Guaifenesin and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2175415b-f07e-50a6-e063-6394a90acabe", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["GSL05Y1MN6", "495W7451VQ"], "rxcui": ["995868"], "spl_set_id": ["88d0994c-4270-4408-8837-bd97510b2118"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["PAI Holdings, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0121-0775-04)", "package_ndc": "0121-0775-04", "marketing_start_date": "20061001"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0775-16)", "package_ndc": "0121-0775-16", "marketing_start_date": "20061001"}], "brand_name": "Guaifenesin and Codeine Phosphate", "product_id": "0121-0775_2175415b-f07e-50a6-e063-6394a90acabe", "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": "0121-0775", "dea_schedule": "CV", "generic_name": "Guaifenesin and Codeine Phosphate", "labeler_name": "PAI Holdings, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Codeine Phosphate", "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": "20061001", "listing_expiration_date": "20261231"}