Home NDC 64543-105 Rescon DM
Product NDC 64543-105
11-digit product format 645430105
Labeler code 64543
Product ID 64543-105_edfec913-38b8-6ac6-e053-2a95a90a6687
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Capellon Pharmaceuticals, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-01-01
Marketing end 0000-00-00
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 2 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], 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], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RESCON DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64543-105-01 64543010501 25 mL in 1 BOTTLE (64543-105-01) 25 ml 1999-01-01 0000-00-00 Yes No Current 64543-105-04 64543010504 118 mL in 1 BOTTLE (64543-105-04) 118 ml 1999-01-01 0000-00-00 No No Current 64543-105-16 64543010516 473 mL in 1 BOTTLE (64543-105-16) 473 ml 1999-01-01 0000-00-00 No No Current