NDC 34362-0302

Gynol II Extra Strength

Nonoxynol

Gynol II Extra Strength is a Vaginal Gel in the Human Otc Drug category. It is labeled and distributed by Caldwell Consumer Health Llc. The primary component is Nonoxynol-9.

• Product ID: 34362-0302_3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941
• NDC: 34362-0302
• Product Type: Human Otc Drug
• Proprietary Name: Gynol II Extra Strength
• Generic Name: Nonoxynol
• Dosage Form: Gel
• Route of Administration: VAGINAL
• Marketing Start Date: 2011-05-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: Caldwell Consumer Health LLC
• Substance Name: NONOXYNOL-9
• Active Ingredient Strength: 3 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 34362-0302-5

1 BOTTLE, WITH APPLICATOR in 1 CARTON (34362-0302-5) > 81 g in 1 BOTTLE, WITH APPLICATOR (34362-0302-1)

• Marketing Start Date: 2020-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 34362-0302-1 [34362030201]

Gynol II Extra Strength GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-05-01

NDC 34362-0302-5 [34362030205]

Gynol II Extra Strength GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NONOXYNOL-9	3 g/100g

OpenFDA Data

• SPL SET ID: eaf86a36-0573-4c39-9324-88919c4d009b
• Manufacturer:
  • Caldwell Consumer Health LLC
• UNII:
  • 48Q180SH9T
• RxNorm Concept Unique ID - RxCUI:
  • 1250090
  • 312029

NDC Crossover Matching brand name "Gynol II Extra Strength" or generic name "Nonoxynol"

NDC	Brand Name	Generic Name
34362-0300	Conceptrol	Nonoxynol
34362-0302	Gynol II	Nonoxynol