Home NDC 55301-547 Cold and Flu
Product NDC 55301-547
11-digit product format 553010547
Labeler code 55301
Product ID 55301-547_5faa7cb9-7a92-4c46-9e28-72186c885b8f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form KIT
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-31
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 Flu
Brand name suffix Day and Night, Severe
Listing expiration 2027-12-31 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 55301-547-08 Cold and FluDay and Night, Severe 2 in 1 CARTON KIT 2 5 55301-547-08 Cold and FluDay and Night, Severe 1 in 1 BLISTER PACK KIT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-547 COLD AND FLU DAY AND NIGHT, SEVERE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [ARMY AND AIR FORCE EXCHANGE SERVICE] 4 Current NDC, 2 package rows 20250416_58d722ef-db67-44ac-a295-dd10e1f5ca1d.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# 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 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 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 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet PSN 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1086991 acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 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 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1086991 APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY 58d722ef-db67-44ac-a295-dd10e1f5ca1d 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55301-547-08 55301054708 2 BLISTER PACK in 1 CARTON (55301-547-08) / 1 KIT in 1 BLISTER PACK 2 blister pack 2023-03-31 No No Current