Home NDC 76162-823 Cold and Flu Severe Daytime/Nighttime
Product NDC 76162-823
11-digit product format 761620823
Labeler code 76162
Product ID 76162-823_1cf9fc29-a15e-4aa0-b169-7eab1ff6d123
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, Doxylamine succinate
Dosage form KIT
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-03
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 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 1297288 Internal RxNorm lookup 1656815 Internal RxNorm lookup 2634364 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 76162-823-12 Cold and Flu Severe Daytime/Nighttime 1 in 1 CARTON KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-823 COLD AND FLU SEVERE DAYTIME/NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE) KIT [TOPCO ASSOCIATES LLC] 1 Current NDC, 1 package rows 20231205_27ade5f8-2003-4dc6-9244-42676791e1f8.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 2634364 {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack GPCK 27ade5f8-2003-4dc6-9244-42676791e1f8 1 2634364 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack PSN 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1297288 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule PSN 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1656815 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule PSN 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1297288 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1656815 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 27ade5f8-2003-4dc6-9244-42676791e1f8 1 2634364 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack SY 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1297288 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 27ade5f8-2003-4dc6-9244-42676791e1f8 1 1656815 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 27ade5f8-2003-4dc6-9244-42676791e1f8 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-823-12 76162082312 1 KIT in 1 CARTON (76162-823-12) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 kit 2023-11-03 No No Current