Home NDC 55319-924 Childrens Mucus and Cough Relief
Product NDC 55319-924
11-digit product format 553190924
Labeler code 55319
Product ID 55319-924_07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e3
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Family Dollar Services, Inc.
Application part341
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-17
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 100 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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Childrens Mucus and Cough Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 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 9D2RTI9KYH 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 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 55319-924-03 Childrens Mucus and Cough Relief 118 mL in 1 BOTTLE LIQUID 118 1 55319-924-03 Childrens Mucus and Cough Relief 1 in 1 CARTON LIQUID 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-924 CHILDRENS MUCUS AND COUGH RELIEF (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [FAMILY DOLLAR SERVICES, INC.] 1 Current NDC, 2 package rows 20240418_07ad76cc-2a6c-4a88-a5e9-5e8f6d1319e3.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-924-03 55319092403 1 BOTTLE in 1 CARTON (55319-924-03) / 118 mL in 1 BOTTLE 1 bottle 2024-04-17 No No Current