NDC 70000-0516

NightTime Cold and Flu Multi Symptom

Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate

NightTime Cold and Flu Multi Symptom is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Cardinal Health (leader) 70000. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID70000-0516_402c815f-c53e-4042-8e93-c61a4f5e9d52
NDC70000-0516
Product TypeHuman Otc Drug
Proprietary NameNightTime Cold and Flu Multi Symptom
Generic NameAcetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-08-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCardinal Health (Leader) 70000
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70000-0516-1

16 BLISTER PACK in 1 CARTON (70000-0516-1) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2019-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70000-0516-2 [70000051602]

NightTime Cold and Flu Multi Symptom CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-08-30

NDC 70000-0516-1 [70000051601]

NightTime Cold and Flu Multi Symptom CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2019-08-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

NDC Crossover Matching brand name "NightTime Cold and Flu Multi Symptom" or generic name "Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate"

NDCBrand NameGeneric Name
70000-0427NightTime Cold and Flu Multi SymptomNightTime Cold and Flu Multi Symptom
62011-0389NightTime Cold and Flu Multi SymptomNightTime Cold and Flu Multi Symptom
62011-0262NightTime Cold and Flu Multi SymptomNightTime Cold and Flu Multi Symptom
67091-395NightTime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE
70000-0516NightTime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.