NDC 69772-440

XL3 XTRA

Acetaminophen Chloepheniramine Maleate Dextromethorphan Phenylepherine Hydrochloride Capsule Liquid Filled

XL3 XTRA is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Teresa Cecena Dba Genesis. The primary component is Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Acetaminophen; Chlorpheniramine Maleate.

Product ID69772-440_1cbb8491-6ef8-45af-e054-00144ff88e88
NDC69772-440
Product TypeHuman Otc Drug
Proprietary NameXL3 XTRA
Generic NameAcetaminophen Chloepheniramine Maleate Dextromethorphan Phenylepherine Hydrochloride Capsule Liquid Filled
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-08-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTeresa Cecena DBA Genesis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength10 mg/mg; mg/mg; mg/mg; mg/mg
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 69772-440-02

12 mg in 1 BLISTER PACK (69772-440-02)
Marketing Start Date2015-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69772-440-01 [69772044001]

XL3 XTRA CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-09-02
Inactivation Date2020-01-31

NDC 69772-440-02 [69772044002]

XL3 XTRA CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-09-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/mg

OpenFDA Data

SPL SET ID:1cbb8491-6ef7-45af-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193292

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