Home NDC 76162-678 COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
Product NDC 76162-678
11-digit product format 761620678
Labeler code 76162
Product ID 76162-678_f108e17b-8973-49d8-9d1d-5781170f9b4b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate, Phenylephrine Hydrochloride
Dosage form KIT
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-11
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 COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
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 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 76162-678-24 COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct 1 in 1 CARTON KIT 1 2
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 97 of 178 · 3,551 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 ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 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 ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1297288 acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule PSN ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1656815 acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule PSN ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1297288 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1656815 acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 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 ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1297288 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2 1656815 APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-678-24 76162067824 1 KIT in 1 CARTON (76162-678-24) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 kit 2025-12-11 No No Current