Home NDC 36800-567-02 topcare day time nite time cold and flu relief
Product NDC 36800-567
Requested package NDC 36800-567-02
11-digit product format 368000567
Labeler code 36800
Product ID 36800-567_a048472c-d123-4ca6-a187-1acba47f2602
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form KIT
Labeler Topco Associates LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-08-07
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-567 TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] 8 Legacy NDC 20241116_6cdc10f7-fd6e-4ea3-a466-97cb59b813f5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-567-02 36800056702 1 KIT in 1 CARTON (36800-567-02) * 355 mL in 1 BOTTLE (36800-335-40) * 355 mL in 1 BOTTLE (36800-522-40) 1 kit 2012-08-07 0000-00-00 No No Current