Home NDC 36800-668 topcare nite time
Product NDC 36800-668
11-digit product format 368000668
Labeler code 36800
Product ID 36800-668_ea8231ee-7167-4be8-bb37-f3a11f8fc355
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2002-12-10
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 30 mg/30mL; mg/30mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
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 · 16 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 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE NITE TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [TOPCO ASSOCIATES LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-668-40 36800066840 355 mL in 1 BOTTLE (36800-668-40) 355 ml 2012-07-16 0000-00-00 No No Current