Home NDC 58552-149 GILTUSS DIABETIC DM
Product NDC 58552-149
11-digit product format 585520149
Labeler code 58552
Product ID 58552-149_40b94d7e-722e-6dce-e063-6394a90a2e10
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 2023-08-09
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 30 mg/10mL
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 GILTUSS DIABETIC DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-149-04 GILTUSS DIABETIC DM 1 in 1 CARTON SOLUTION 1 4 58552-149-04 GILTUSS DIABETIC DM 118 mL in 1 BOTTLE SOLUTION 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-149 GILTUSS DIABETIC DM (DEXTROMETHORPHAN HBR) SOLUTION [GIL PHARMACEUTICAL CORP] 3 Current NDC, 2 package rows 20241027_bd367ce1-996b-45bc-865e-b6aafe0ea7b0.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 Sample Exclude flag Status 58552-149-04 58552014904 1 BOTTLE in 1 CARTON (58552-149-04) / 118 mL in 1 BOTTLE 1 bottle 2023-08-09 No No Current