Home NDC 12539-779 NeoTuss Plus
Product NDC 12539-779
11-digit product format 125390779
Labeler code 12539
Product ID 12539-779_463c45eb-d68e-f00f-e063-6394a90acc91
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-06
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 4; 30; 7.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 7.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2167750 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 12539-779-01 NeoTuss Plus 30 mL in 1 BOTTLE LIQUID 30 2 12539-779-16 NeoTuss Plus 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 12539-779 NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] 1 Current NDC, 1 package rows 20250322_2fabd782-14dc-1d1b-e063-6394a90af428.zip 12539-779 NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] 1 Current NDC, 1 package rows 20250303_2f3c6b38-7236-899b-e063-6294a90aabde.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 12539-779-01 12539077901 30 mL in 1 BOTTLE (12539-779-01) 30 ml 2025-02-28 No No Current 12539-779-16 12539077916 474 mL in 1 BOTTLE (12539-779-16) 474 ml 2025-03-06 No No Current