Home NDC 0363-1144 tussin dm max
Product NDC 0363-1144
11-digit product format 003631144
Labeler code 0363
Product ID 0363-1144_6dca6e0b-1e4e-4d4a-b085-7ae9a0c7fe8a
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Walgreen Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-24
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 mg/20mL; mg/20mL
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 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 tussin dm max
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 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 0363-1144-26 tussin dm max 118 mL in 1 BOTTLE SOLUTION 118 3 0363-1144-26 tussin dm max 1 in 1 CARTON SOLUTION 1 3 0363-1144-34 tussin dm max 237 mL in 1 BOTTLE SOLUTION 237 3 0363-1144-34 tussin dm max 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1144 TUSSIN DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [WALGREEN COMPANY] 3 Current NDC, Legacy NDC, 4 package rows 20241106_756794b0-8d3b-4732-947c-a407caf400e2.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 · 3,550 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 0363-1144-26 00363114426 1 BOTTLE in 1 CARTON (0363-1144-26) / 118 mL in 1 BOTTLE 1 bottle 2022-05-24 0000-00-00 No No Current 0363-1144-34 00363114434 1 BOTTLE in 1 CARTON (0363-1144-34) / 237 mL in 1 BOTTLE 1 bottle 2022-05-24 0000-00-00 No No Current