Home NDC 0363-0058 Cold and Congestion
Product NDC 0363-0058
11-digit product format 003630058
Labeler code 0363
Product ID 0363-0058_7febd3a1-07d3-4499-bd13-0b876e1c20f8
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCI, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Walgreens
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-03-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 12.5; 5 mg/10mL; mg/10mL
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 Cold and Congestion
Brand name suffix Childrens Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1236048 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 0363-0058-04 Cold and CongestionChildrens Nighttime 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0058 COLD AND CONGESTION CHILDRENS NIGHTTIME (DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL) LIQUID [WALGREENS] 6 Current NDC, Legacy NDC, 1 package rows 20231010_a7847413-e556-4f88-8a7f-a8528afbe927.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 0363-0058-04 00363005804 118 mL in 1 BOTTLE, PLASTIC (0363-0058-04) 118 ml 2016-03-31 0000-00-00 No No Current