NDC 76260-107

Aqua Maris Kids Fast Acting Decongestant

Xylometazoline Hcl

Aqua Maris Kids Fast Acting Decongestant is a Nasal Spray in the Human Otc Drug category. It is labeled and distributed by Jgl North America Llc. The primary component is Xylometazoline Hydrochloride.

Product ID76260-107_28ca2b5e-5642-46ca-9303-8e9a19bec60d
NDC76260-107
Product TypeHuman Otc Drug
Proprietary NameAqua Maris Kids Fast Acting Decongestant
Generic NameXylometazoline Hcl
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2010-09-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameJGL North America LLC
Substance NameXYLOMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength0 mg/10mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76260-107-05

1 BOTTLE, SPRAY in 1 CARTON (76260-107-05) > 10 mL in 1 BOTTLE, SPRAY
Marketing Start Date2010-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76260-107-05 [76260010705]

Aqua Maris Kids Fast Acting Decongestant SPRAY
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-09-27
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
XYLOMETAZOLINE HYDROCHLORIDE.05 mg/10mL

OpenFDA Data

SPL SET ID:0c1f137f-2318-4551-9792-d25542e4d953
Manufacturer
UNII

NDC Crossover Matching brand name "Aqua Maris Kids Fast Acting Decongestant" or generic name "Xylometazoline Hcl"

NDCBrand NameGeneric Name
76260-106Aqua MarisXylometazoline HCL
76260-107Aqua Maris KidsXylometazoline HCL
44237-007SinosilXylometazoline HCL

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