Home NDC 58657-500 Codeine-Guaifenesin
Product NDC 58657-500
11-digit product format 586570500
Labeler code 58657
Product ID 58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4
Type HUMAN OTC DRUG
Nonproprietary name Codeine Phosphate and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Method Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-01
Substance CODEINE PHOSPHATE; GUAIFENESIN
Active strength 10; 100 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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Codeine-Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GSL05Y1MN6 Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 995868 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 58657-500-04 Codeine-Guaifenesin 120 mL in 1 BOTTLE SOLUTION 120 16 58657-500-16 Codeine-Guaifenesin 473 mL in 1 BOTTLE SOLUTION 473 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 GUAIFENESIN ACTIVE MOIETY 495W7451VQ CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 SORBITOL INACTIVE INGREDIENT 506T60A25R CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-500 CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [METHOD PHARMACEUTICALS, LLC] 14 Current NDC, Legacy NDC, 2 package rows 20241126_fe126254-6ee6-48c3-965c-96e4276a5314.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
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 58657-500-04 58657050004 120 mL in 1 BOTTLE (58657-500-04) 120 ml 2014-04-01 0000-00-00 No No Current 58657-500-16 58657050016 473 mL in 1 BOTTLE (58657-500-16) 473 ml 2014-04-01 0000-00-00 No No Current