Home NDC 36800-297 Cough and Runny Nose
Product NDC 36800-297
11-digit product format 368000297
Labeler code 36800
Product ID 36800-297_5fc6d0d3-14f3-40f7-a903-f81a91ac9244
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
Dosage form SUSPENSION
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-31
Marketing end 2027-06-01
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 160; 1; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
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 Cough and Runny Nose
Brand name suffix Childrens Plus Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL CHLORPHENIRAMINE MALEATE 1 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086750 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 36800-297-04 Cough and Runny NoseChildrens Plus 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 8 36800-297-04 Cough and Runny NoseChildrens Plus 1 in 1 BOX SUSPENSION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-297 COUGH AND RUNNY NOSE CHILDRENS PLUS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [TOP CARE (TOPCO ASSOCIATES LLC)] 8 Current NDC, Legacy NDC, 2 package rows 20240619_6f04bd51-093c-4624-aef3-0145ac387386.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 177 · 3,534 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-297-04 36800029704 1 BOTTLE, PLASTIC in 1 BOX (36800-297-04) / 118 mL in 1 BOTTLE, PLASTIC 2015-12-31 2027-06-01 No No Current