Home NDC 67091-355 Winco Foods Childrens Multi Symptom Cold
Product NDC 67091-355
11-digit product format 670910355
Labeler code 67091
Product ID 67091-355_531a4343-0b95-456f-90cd-2c55769c3ae3
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form SUSPENSION
Route ORAL
Labeler WINCO FOODS, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
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 Winco Foods Childrens Multi Symptom Cold
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
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 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 67091-355-18 Winco Foods Childrens Multi Symptom Cold 1 in 1 CARTON SUSPENSION 1 6 67091-355-18 Winco Foods Childrens Multi Symptom Cold 118 mL in 1 BOTTLE SUSPENSION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-355 WINCO FOODS CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [WINCO FOODS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241121_1d02b32a-e88d-4c70-b66d-7bdc22c25a43.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67091-355-18 67091035518 1 BOTTLE in 1 CARTON (67091-355-18) / 118 mL in 1 BOTTLE 1 bottle 2020-03-30 0000-00-00 No No Current