Home NDC 12539-555 NeoTuss S/F
Product NDC 12539-555
11-digit product format 125390555
Labeler code 12539
Product ID 12539-555_463c3e8f-7445-efdd-e063-6394a90a660b
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-28
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 30 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 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 NeoTuss S/F
Brand name suffix Grape-Menthol Flavor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 30 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 1147924 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 12539-555-01 NeoTuss S/FGrape-Menthol Flavor 30 mL in 1 BOTTLE LIQUID 30 2 12539-555-16 NeoTuss S/FGrape-Menthol Flavor 474 mL in 1 BOTTLE LIQUID 474 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12539-555 NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] 1 Current NDC, 1 package rows 20250322_2fac3425-32f0-38d6-e063-6394a90a6e7a.zip 12539-555 NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] 1 Current NDC, 1 package rows 20250303_2f3df82c-1926-5238-e063-6294a90a7bbf.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 Sample Exclude flag Status 12539-555-01 12539055501 30 mL in 1 BOTTLE (12539-555-01) 30 ml 2025-02-28 No No Current 12539-555-16 12539055516 474 mL in 1 BOTTLE (12539-555-16) 474 ml 2025-03-06 No No Current