Home NDC 41163-813 equaline adult tussin
Product NDC 41163-813
11-digit product format 411630813
Labeler code 41163
Product ID 41163-813_48443958-fb98-4c9d-b5f9-3738a8fea481
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-08
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 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 equaline adult tussin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 200 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 1790650 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 41163-813-26 equaline adult tussin 1 in 1 CARTON SOLUTION 1 4 41163-813-26 equaline adult tussin 118 mL in 1 BOTTLE SOLUTION 118 4 41163-813-34 equaline adult tussin 1 in 1 CARTON SOLUTION 1 4 41163-813-34 equaline adult tussin 237 mL in 1 BOTTLE SOLUTION 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-813 EQUALINE ADULT TUSSIN (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [UNITED NATURAL FOODS, INC. DBA UNFI] 4 Current NDC, Legacy NDC, 4 package rows 20241112_f7c753f8-4b12-4797-a599-736d597bc1bc.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 97 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 Marketing end Sample Exclude flag Status 41163-813-26 41163081326 1 BOTTLE in 1 CARTON (41163-813-26) / 118 mL in 1 BOTTLE 1 bottle 2022-06-23 0000-00-00 No No Current 41163-813-34 41163081334 1 BOTTLE in 1 CARTON (41163-813-34) / 237 mL in 1 BOTTLE 1 bottle 2022-06-08 0000-00-00 No No Current