NDC 11822-3416

Day Time with PE

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hci

Day Time with PE is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rite Aid Corporation. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID11822-3416_2f10aec5-a077-4443-8dc6-53b76f031e0c
NDC11822-3416
Product TypeHuman Otc Drug
Proprietary NameDay Time with PE
Generic NameAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hci
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2009-08-13
Marketing End Date2019-12-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRite Aid Corporation
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN

Packaging

NDC 11822-3416-1

296 mL in 1 BOTTLE, PLASTIC (11822-3416-1)
Marketing Start Date2009-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11822-3416-1 [11822341601]

Day Time with PE LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-08-13
Marketing End Date2019-12-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:dbf1a3bf-524c-4079-91dc-edef40c0d3ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113705
  • UPC Code
  • 0011822556439
  • NDC Crossover Matching brand name "Day Time with PE" or generic name "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hci"

    NDCBrand NameGeneric Name
    68016-142Day Time with PEDay Time with PE
    11822-3416Day TimeAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCI

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