Home NDC 76281-517 SEVERE CONGESTION and COUGH MAX
Product NDC 76281-517
11-digit product format 762810517
Labeler code 76281
Product ID 76281-517_1758bfe6-e9c6-445d-9a3c-55c24ba5bde1
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, GUaifenesin, Phenylephrine HCL
Dosage form LIQUID
Route ORAL
Labeler AptaPharma Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20; 400; 10 mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 SEVERE CONGESTION and COUGH MAX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ 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 1043543 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 76281-517-25 SEVERE CONGESTION and COUGH MAX 177 mL in 1 BOTTLE LIQUID 177 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-517 SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.] 1 Current NDC, 1 package rows 20240202_17a07d2d-f2da-4e51-9a77-6f0c174987bb.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 76281-517-25 76281051725 177 mL in 1 BOTTLE (76281-517-25) 177 ml 2024-01-30 No No Current