Home NDC 0363-0853 Daytime Cold and Flu
Product NDC 0363-0853
11-digit product format 003630853
Labeler code 0363
Product ID 0363-0853_13b1a0d2-6b18-a20f-e063-6294a90a35b2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophine Dextromethorphan HBr Phenylphrine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler WALGREENS
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-15
Substance PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 5; 10; 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 Daytime Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086997 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 0363-0853-07 Daytime Cold and Flu 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 3 0363-0853-07 Daytime Cold and Flu 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 0363-0853-16 Daytime Cold and Flu 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 3 0363-0853-16 Daytime Cold and Flu 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3 0363-0853-24 Daytime Cold and Flu 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3 0363-0853-24 Daytime Cold and Flu 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-0853 DAYTIME COLD AND FLU (ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS] 3 Current NDC, Legacy NDC, 6 package rows 20240316_d315bc95-1b46-75df-e053-2a95a90a6c66.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 0363-0853-07 00363085307 1 BLISTER PACK in 1 CARTON (0363-0853-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2023-07-03 No No Current 0363-0853-16 00363085316 2 BLISTER PACK in 1 CARTON (0363-0853-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2021-10-15 0000-00-00 No No Current 0363-0853-24 00363085324 2 BLISTER PACK in 1 CARTON (0363-0853-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2021-10-15 0000-00-00 No No Current