Home NDC 67091-323 Severe Cold and Cough Nighttime
Product NDC 67091-323
11-digit product format 670910323
Labeler code 67091
Product ID 67091-323_7e40dc63-8fce-4391-a0d1-5eeefc43b4c8
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler WinCo Foods, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 25; 10 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Cold and Cough Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 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 1659960 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 67091-323-06 Severe Cold and Cough Nighttime 1 in 1 PACKET POWDER, FOR SOLUTION 1 7 67091-323-06 Severe Cold and Cough Nighttime 6 in 1 CARTON POWDER, FOR SOLUTION 6 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-323 SEVERE COLD AND COUGH NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [WINCO FOODS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241121_dc56197c-c108-4b35-b791-dde5c3384ddd.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 67091-323-06 67091032306 6 PACKET in 1 CARTON (67091-323-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2018-08-01 0000-00-00 No No Current