Home NDC 21130-379 Childrens Cold and Cough
Product NDC 21130-379
11-digit product format 211300379
Labeler code 21130
Product ID 21130-379_699a52c6-053a-43f9-b7fc-d719aead253d
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Safeway, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-31
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 6.25; 2.5 mg/5mL; mg/5mL
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 Childrens Cold and Cough
Brand name suffix Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21130-379-04 Childrens Cold and CoughNighttime 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 7 21130-379-04 Childrens Cold and CoughNighttime 1 in 1 BOX LIQUID 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-379 CHILDRENS COLD AND COUGH NIGHTTIME (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SAFEWAY, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240517_cbbec807-f882-4c6a-b1cd-c7fd5ce70cad.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 Marketing start Marketing end Sample Exclude flag Status 21130-379-04 21130037904 1 BOTTLE, PLASTIC in 1 BOX (21130-379-04) / 118 mL in 1 BOTTLE, PLASTIC 2015-12-31 0000-00-00 No No Current