Home NDC 68163-541 Nighttime Severe Cold and Cough
Product NDC 68163-541
11-digit product format 681630541
Labeler code 68163
Product ID 68163-541_7fd2aabb-24db-49c6-a943-74dc35da3877
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler RARITAN PHARMACEUTICALS INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-03-22
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 Nighttime Severe Cold and Cough
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 68163-541-06 Nighttime Severe Cold and Cough 6 in 1 CARTON POWDER, FOR SOLUTION 6 7 68163-541-06 Nighttime Severe Cold and Cough 1 in 1 PACKET POWDER, FOR SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-541 NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE) POWDER, FOR SOLUTION [RARITAN PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 2 package rows 20241124_9819155b-2713-42be-867e-16605e7643d0.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 177 · 3,534 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 68163-541-06 68163054106 6 PACKET in 1 CARTON (68163-541-06) / 1 POWDER, FOR SOLUTION in 1 PACKET 6 packet 2019-03-22 0000-00-00 No No Current