Home NDC 79481-5034 COLD AND FLU SEVERE
Product NDC 79481-5034
11-digit product format 794815034
Labeler code 79481
Product ID 79481-5034_6a3ee451-8569-46b6-b65b-f5d7b8968e3b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form KIT
Labeler Meijer Distribution, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-08
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 COLD AND FLU SEVERE
Brand name suffix Daytime, Nighttime
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086991 Internal RxNorm lookup 1110988 Internal RxNorm lookup 2634819 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 79481-5034-8 COLD AND FLU SEVEREDaytime, Nighttime 1 in 1 BLISTER PACK KIT 1 3 79481-5034-8 COLD AND FLU SEVEREDaytime, Nighttime 2 in 1 CARTON KIT 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79481-5034 COLD AND FLU SEVERE DAYTIME, NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [MEIJER DISTRIBUTION, INC.] 2 Current NDC, 2 package rows 20241109_04715af5-e861-496c-834a-233eb7312556.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2634819 {1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack GPCK 04715af5-e861-496c-834a-233eb7312556 3 2634819 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack PSN 04715af5-e861-496c-834a-233eb7312556 3 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet PSN 04715af5-e861-496c-834a-233eb7312556 3 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN 04715af5-e861-496c-834a-233eb7312556 3 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 04715af5-e861-496c-834a-233eb7312556 3 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 04715af5-e861-496c-834a-233eb7312556 3 2634819 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack SY 04715af5-e861-496c-834a-233eb7312556 3 1086991 APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 04715af5-e861-496c-834a-233eb7312556 3 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 04715af5-e861-496c-834a-233eb7312556 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79481-5034-8 79481503408 2 BLISTER PACK in 1 CARTON (79481-5034-8) / 1 KIT in 1 BLISTER PACK 2 blister pack 2024-11-08 No No Current