Home NDC 64543-097 Rescon
Product NDC 64543-097
11-digit product format 645430097
Labeler code 64543
Product ID 64543-097_edfea55f-1a20-f40e-e053-2a95a90a9093
Type HUMAN OTC DRUG
Nonproprietary name Dexchlorpheniramine Maleate and Pseudoephedrine Hydrochloride
Dosage form TABLET, MULTILAYER
Route ORAL
Labeler Capellon Pharmaceuticals, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-03-30
Marketing end 0000-00-00
Substance DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 2 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [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 · 36 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 DEXCHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT B10YD955QW RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 DEXCHLORPHENIRAMINE ACTIVE MOIETY 3Q9Q0B929N RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RESCON (DEXCHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER [CAPELLON PHARMACEUTICALS, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64543-097-02 64543009702 1 TABLET, MULTILAYER in 1 POUCH (64543-097-02) 2012-03-30 0000-00-00 Yes No Current 64543-097-90 64543009790 90 TABLET, MULTILAYER in 1 BOTTLE (64543-097-90) 2012-03-30 0000-00-00 No No Current