NDC 64539-016

Glizigen Single Dose Intimate Gel

Glycerin

Glizigen Single Dose Intimate Gel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Catalysis, Sl. The primary component is Glycerin.

Product ID64539-016_67a3290e-7c56-acd6-e053-2a91aa0ac440
NDC64539-016
Product TypeHuman Otc Drug
Proprietary NameGlizigen Single Dose Intimate Gel
Generic NameGlycerin
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-03-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameCatalysis, SL
Substance NameGLYCERIN
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64539-016-02

1 DOSE PACK in 1 PACKAGE (64539-016-02) > 5 mL in 1 DOSE PACK (64539-016-01)
Marketing Start Date2018-03-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64539-016-02 [64539001602]

Glizigen Single Dose Intimate Gel GEL
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-17
Marketing End Date2019-01-01

NDC 64539-016-01 [64539001601]

Glizigen Single Dose Intimate Gel GEL
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-17
Marketing End Date2019-01-01

Drug Details

Active Ingredients

IngredientStrength
GLYCERIN.5 mg/mL

OpenFDA Data

SPL SET ID:67a32901-bd33-5d8b-e053-2991aa0ab943
Manufacturer
UNII

NDC Crossover Matching brand name "Glizigen Single Dose Intimate Gel" or generic name "Glycerin"

NDCBrand NameGeneric Name
64539-016Glizigen Single Dose Intimate GelGlizigen Single Dose Intimate Gel
20151-0743 en 1 Cleanser. Deep CleansingGlycerin
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20151-104Age Defense Pro Prebiotic Technology EconatureGlycerin
0132-0075FleetGlycerin
0132-0079FleetGlycerin
0132-0185FleetGlycerin
11716-1189FREDS DRY EYE RELIEFGLYCERIN
0713-0101GlycerinGlycerin
11822-3312GlycerinGlycerin
11822-3321GlycerinGlycerin
17856-0221GlycerinGlycerin
17856-0222GlycerinGlycerin
20151-093Hydra Lifting Firming Fresh Serum 24HGlycerin
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20151-102Lightening Brightening Moisturizing SerumGlycerin
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0132-0081Pedia-LaxGlycerin
0132-0190Pedia-LaxGlycerin
0132-0195Pedia-LaxGlycerin
0713-0102Pediatric GlycerinGlycerin
20151-086Renovating Regenerating Moisturizing CreamGlycerin
20151-085Renovating Regenerating Nourishing CreamGlycerin
20151-068Renovating Regenerating SerumGlycerin
20151-095Shine Control Sebum Regulating GelGlycerin
11716-1629SHOPKO DRY EYE RELIEFGLYCERIN
20151-088Vitalizing Energizing Nourishing CreamGlycerin

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