Home NDC 58552-144 Childrens Giltuss Honey DM Cough
Product NDC 58552-144
11-digit product format 585520144
Labeler code 58552
Product ID 58552-144_40b8c1dc-4837-be7b-e063-6394a90a26f8
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form SOLUTION
Route ORAL
Labeler Gil Pharmaceutical Corp
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-22
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/5mL
Pharmacologic classes 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 Childrens Giltuss Honey DM Cough
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1090496 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-144-04 Childrens Giltuss Honey DM Cough 1 in 1 CARTON SOLUTION 1 6 58552-144-04 Childrens Giltuss Honey DM Cough 118 mL in 1 BOTTLE SOLUTION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-144 CHILDRENS GILTUSS HONEY DM COUGH (DEXTROMETHORPHAN HBR) SOLUTION [GIL PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 2 package rows 20241027_a8c5027f-9701-fb07-e053-2a95a90a6029.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 177 · 3,534 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 58552-144-04 58552014404 1 BOTTLE in 1 CARTON (58552-144-04) / 118 mL in 1 BOTTLE 1 bottle 2020-06-22 0000-00-00 No No Current