guaifenesin and codeine phosphate

Generic: guaifenesin and codeine phosphate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin and codeine phosphate
Generic Name guaifenesin and codeine phosphate
Labeler preferred pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8361
Product ID 68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number MO12
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 687888361
Hyphenated Format 68788-8361

Supplemental Identifiers

RxCUI
995868
UNII
GSL05Y1MN6 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 MO12 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (68788-8361-1)
source: ndc

Packages (1)

68788-8361-1 118 mL in 1 BOTTLE (68788-8361-1)

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": "09ad5feb-c680-4634-8790-ab23bf0b8336", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["GSL05Y1MN6", "495W7451VQ"], "rxcui": ["995868"], "spl_set_id": ["f5265ae5-db8e-428d-90e9-5eda6a8a22bd"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (68788-8361-1)", "package_ndc": "68788-8361-1", "marketing_start_date": "20230201"}], "brand_name": "Guaifenesin and Codeine Phosphate", "product_id": "68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336", "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": "68788-8361", "dea_schedule": "CV", "generic_name": "Guaifenesin and Codeine Phosphate", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "MO12", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}