Home NDC 55758-013 SanaTos Children Cough and Congestion Cherry
Product NDC 55758-013
11-digit product format 557580013
Labeler code 55758
Product ID 55758-013_177ee8db-2b19-2923-e063-6294a90a1c7b
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HBr and GUAIFENESIN
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-01
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 100; 5 mg/5mL; mg/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 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 SanaTos Children Cough and Congestion Cherry
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/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 55758-013-04 SanaTos Children Cough and Congestion Cherry 118 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 118 4 55758-013-04 SanaTos Children Cough and Congestion Cherry 1 in 1 BOX LIQUID 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-013 SANATOS CHILDREN COUGH AND CONGESTION CHERRY (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [PHARMADEL LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240504_60437d86-9e13-8d8a-e053-2991aa0a2317.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 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55758-013-04 55758001304 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-013-04) / 118 mL in 1 BOTTLE, WITH APPLICATOR 2016-01-01 0000-00-00 No No Current