Home NDC 0682-0475 MAR-COF CG
Product NDC 0682-0475
11-digit product format 006820475
Labeler code 0682
Product ID 0682-0475_13b802bb-b30a-864a-e063-6394a90a4dfd
Type HUMAN OTC DRUG
Nonproprietary name CODEINE PHOSPHATE and GUAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler Marnel Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-12-01
Substance CODEINE PHOSPHATE; GUAIFENESIN
Active strength 7.5; 225 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Ask your doctor before use if you have a persistent cough, this may be a sign of a serious condition you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema you have a cough that is accompanied by excessive phlegm (mucus) you have chronic pulmonary disease or shortness of breath giving to a child who is taking other drugs When using this product giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age may cause or aggravate constipation Stop use and ask a doctor if symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base MAR-COF CG
Brand name suffix Expectorant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 7.5 mg/5mL GUAIFENESIN 225 mg/5mL
Harmonized Identifiers# Field, Values table Field Values Unii GSL05Y1MN6, 495W7451VQ Rxcui 995441, 995443
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0682-0475-16 MAR-COF CGExpectorant 473 mL in 1 BOTTLE SYRUP 473 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTCALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0682-0475 MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTICALS, LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240316_60a41229-b125-43d8-b2b4-0bf40feed764.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0682-0475-16 00682047516 473 mL in 1 BOTTLE (0682-0475-16) 473 ml 2008-12-01 0000-00-00 No No Current