NDC 28623-250

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 Progela, S.a. De C.v.. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID28623-250_78879103-1247-035c-e053-2991aa0a1784
NDC28623-250
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 Date2013-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameProgela, 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 28623-250-01

20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (28623-250-01)
Marketing Start Date2013-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 28623-250-01 [28623025001]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-03-01
Marketing End Date2018-10-15

NDC 28623-250-12 [28623025012]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-08-22
Marketing End Date2020-01-01

NDC 28623-250-06 [28623025006]

Cough and Cold XL3 Xtra CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-15
Marketing End Date2020-01-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN250 mg/1

OpenFDA Data

SPL SET ID:1d878c3c-dd0e-4024-ac98-7053748d164b
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

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