Home NDC 67091-338 Night Time Cold and Flu Relief
Product NDC 67091-338
11-digit product format 670910338
Labeler code 67091
Product ID 67091-338_b1cfea7f-a2f7-41ea-8a03-554f91196b99
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler WinCo Foods, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Night Time Cold and Flu Relief
Brand name suffix Multi Symptom
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67091-338-24 Night Time Cold and Flu ReliefMulti Symptom 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 5 67091-338-24 Night Time Cold and Flu ReliefMulti Symptom 24 in 1 CARTON CAPSULE, LIQUID FILLED 24 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-338 NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240504_d9d3d087-ca74-4916-9e6d-93d67efc463e.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 Marketing end Sample Exclude flag Status 67091-338-24 67091033824 24 BLISTER PACK in 1 CARTON (67091-338-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 24 blister pack 2019-06-01 0000-00-00 No No Current