Home NDC 55758-307 SanaTos Mucus Relief Cold Toddlers
Product NDC 55758-307
11-digit product format 557580307
Labeler code 55758
Product ID 55758-307_2d58d9b1-2c02-42e2-e063-6294a90a205c
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-17
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 50; 2.5 mg/2.5mL; mg/2.5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 SanaTos Mucus Relief Cold Toddlers
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 50 mg/2.5mL DEXTROMETHORPHAN HYDROBROMIDE 2.5 mg/2.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-307-02 SanaTos Mucus Relief Cold Toddlers 59 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 59 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-307 SANATOS MUCUS RELIEF COLD TODDLERS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [PHARMADEL LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250210_60672feb-1421-651e-e053-2a91aa0af41d.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 73 of 178 · 3,551 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 55758-307-02 55758030702 59 mL in 1 BOTTLE, WITH APPLICATOR (55758-307-02) 59 ml 2017-10-17 0000-00-00 No No Current