Home NDC 63868-291 Quality Choice Severe Cold and Cough Nighttime
Product NDC 63868-291
11-digit product format 638680291
Labeler code 63868
Product ID 63868-291_451d39c3-28b2-7b9b-e063-6294a90a18e3
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Chain Drug Manufacturing Assn
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-16
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 2026-12-31
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 Quality Choice Severe Cold and Cough Nighttime
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-291-06 Quality Choice Severe Cold and Cough Nighttime 1 in 1 PACKET POWDER, FOR SOLUTION 1 8 63868-291-06 Quality Choice Severe Cold and Cough Nighttime 6 in 1 CARTON POWDER, FOR SOLUTION 6 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-291 QUALITY CHOICE SEVERE COLD AND COUGH NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [CHAIN DRUG MANUFACTURING ASSN] 7 Current NDC, Legacy NDC, 2 package rows 20241220_ce658dd5-b683-436e-b16b-0c06f6f87fd9.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 · 3,551 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 63868-291-06 63868029106 6 PACKET in 1 CARTON (63868-291-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2018-07-16 0000-00-00 No No Current