NDC 63868-672

Nighttime Cold and Flu Maximum Strength

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate,phenylephrine Hcl

Nighttime Cold and Flu Maximum Strength is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Quality Choice (chain Drug Marketing Association). The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Doxylamine Succinate.

Product ID63868-672_5af90113-4950-4d77-9dfb-441b32c00404
NDC63868-672
Product TypeHuman Otc Drug
Proprietary NameNighttime Cold and Flu Maximum Strength
Generic NameAcetaminophen, Dextromethorphan Hbr, Doxylamine Succinate,phenylephrine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-07-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameQUALITY CHOICE (Chain Drug Marketing Association)
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63868-672-16

16 BLISTER PACK in 1 CARTON (63868-672-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2018-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-672-16 [63868067216]

Nighttime Cold and Flu Maximum Strength CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-07-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

NDC Crossover Matching brand name "Nighttime Cold and Flu Maximum Strength" or generic name "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate,phenylephrine Hcl"

NDCBrand NameGeneric Name
11673-460Nighttime Cold and Flu Maximum StrengthNighttime Cold and Flu Maximum Strength
55910-460Nighttime Cold and Flu Maximum StrengthNighttime Cold and Flu Maximum Strength
0363-0460Nighttime Cold and Flu Maximum StrengthNighttime Cold and Flu Maximum Strength
63868-672Nighttime Cold and FluAcetaminophen, Dextromethorphan HBr, Doxylamine succinate,Phenylephrine HCL

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