Home NDC 55301-620 Severe Cold and Flu Relief
Product NDC 55301-620
11-digit product format 553010620
Labeler code 55301
Product ID 55301-620_ee4cf11c-0972-4a55-87bb-21a4f52f742a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
Dosage form KIT
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-31
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 Severe Cold and Flu Relief
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 1110988 Internal RxNorm lookup 1546881 Internal RxNorm lookup 2634817 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 55301-620-08 Severe Cold and Flu ReliefDaytime/Nighttime 1 in 1 CARTON KIT 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-620 SEVERE COLD AND FLU RELIEF DAYTIME/NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [ARMY AND AIR FORCE EXCHANGE SERVICE] 9 Current NDC, Legacy NDC, 1 package rows 20241116_1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e.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 2634817 {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 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 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 2634817 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack PSN 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1546881 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet PSN 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1546881 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 2634817 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet) Pack SY 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1546881 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet SY 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55301-620-08 55301062008 1 KIT in 1 CARTON (55301-620-08) * 8 TABLET, FILM COATED in 1 BLISTER PACK * 8 TABLET, FILM COATED in 1 BLISTER PACK 1 kit 2018-08-31 0000-00-00 No No Current