Home NDC 49483-726 Maximum strength Day cold and flu and Night severe cold and flu
Product NDC 49483-726
11-digit product format 494830726
Labeler code 49483
Product ID 49483-726_fff69901-965d-5372-e053-6394a90a29c2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophe, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl Tablets
Dosage form KIT
Labeler TIME CAP LABORATORIES,INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-21
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 Maximum strength Day cold and flu and Night severe cold and flu
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 2549037 Internal RxNorm lookup 2560237 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 49483-726-64 Maximum strength Day cold and flu and Night severe cold and flu 4 in 1 CARTON KIT 4 1 49483-726-64 Maximum strength Day cold and flu and Night severe cold and flu 1 in 1 BLISTER PACK KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-726 MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU (ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS) KIT [TIME CAP LABORATORIES,INC] 1 Current NDC, 2 package rows 20231021_fff69901-965c-5372-e053-6394a90a29c2.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 · 3,550 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2560237 {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) } Pack GPCK fff69901-965c-5372-e053-6394a90a29c2 1 2560237 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 / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack PSN fff69901-965c-5372-e053-6394a90a29c2 1 1110988 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet PSN fff69901-965c-5372-e053-6394a90a29c2 1 2549037 acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet PSN fff69901-965c-5372-e053-6394a90a29c2 1 1110988 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SCD fff69901-965c-5372-e053-6394a90a29c2 1 2549037 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet SCD fff69901-965c-5372-e053-6394a90a29c2 1 2560237 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 / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack SY fff69901-965c-5372-e053-6394a90a29c2 1 1110988 APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet SY fff69901-965c-5372-e053-6394a90a29c2 1 2549037 APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG Oral Tablet SY fff69901-965c-5372-e053-6394a90a29c2 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49483-726-64 49483072664 4 BLISTER PACK in 1 CARTON (49483-726-64) / 1 KIT in 1 BLISTER PACK * 6 TABLET in 1 BLISTER PACK * 4 TABLET in 1 BLISTER PACK 4 blister pack 2023-09-21 No No Current