NDC 63654-800

Cough and Cold XL3 Xtra

Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride

Cough and Cold XL3 Xtra is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Selder, S.a. De C.v.. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID63654-800_798de183-426c-b616-e053-2a91aa0a2534
NDC63654-800
Product TypeHuman Otc Drug
Proprietary NameCough and Cold XL3 Xtra
Generic NameAcetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2011-11-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSelder, S.A. de C.V.
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength250 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63654-800-06

6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (63654-800-06)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63654-800-12 [63654080012]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-22

NDC 63654-800-06 [63654080006]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-15

NDC 63654-800-20 [63654080020]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-11-15
Marketing End Date2018-10-15

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN250 mg/1

OpenFDA Data

SPL SET ID:da5b31dd-becd-471a-9392-d0ee4b8f9539
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193292
  • NDC Crossover Matching brand name "Cough and Cold XL3 Xtra" or generic name "Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride"

    NDCBrand NameGeneric Name
    28623-250Cough and ColdAcetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
    58596-001Cough and ColdAcetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
    63654-800Cough and ColdAcetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride
    76095-015Cough and ColdAcetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride

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