NDC 68915-280

Guardian Vaginal

Benzalkonium Chloride

Guardian Vaginal is a Vaginal Douche in the Human Otc Drug category. It is labeled and distributed by Eastern Century Pharmaceuticals. The primary component is Benzalkonium Chloride.

• Product ID: 68915-280_52dddb14-2764-6b8d-e054-00144ff8d46c
• NDC: 68915-280
• Product Type: Human Otc Drug
• Proprietary Name: Guardian Vaginal
• Generic Name: Benzalkonium Chloride
• Dosage Form: Douche
• Route of Administration: VAGINAL
• Marketing Start Date: 2011-05-23
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: Eastern Century Pharmaceuticals
• Substance Name: BENZALKONIUM CHLORIDE
• Active Ingredient Strength: 1 mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 68915-280-02

1 BOTTLE in 1 BOX (68915-280-02) > 5.5 mL in 1 BOTTLE (68915-280-01)

• Marketing Start Date: 2011-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68915-280-02 [68915028002]

Guardian Vaginal DOUCHE

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-23

NDC 68915-280-01 [68915028001]

Guardian Vaginal DOUCHE

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-23

Drug Details

Active Ingredients

Ingredient	Strength
BENZALKONIUM CHLORIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: 1605ba44-02b7-4c72-9fec-89a5aa962b44
• Manufacturer:
  • Eastern Century Pharmaceuticals
• UNII:
  • F5UM2KM3W7
• RxNorm Concept Unique ID - RxCUI:
  • 1111013

NDC Crossover Matching brand name "Guardian Vaginal" or generic name "Benzalkonium Chloride"

NDC	Brand Name	Generic Name
68915-280	Guardian Vaginal	Guardian Vaginal
0363-7110	Antiseptic	benzalkonium chloride
0498-0402	Antiseptic	Benzalkonium chloride
0498-0501	Antiseptic Towelette	Benzalkonium chloride
0404-6735	BZK	benzalkonium chloride
0404-5824	BZK Towelette	BENZALKONIUM CHLORIDE
0404-4445	Hand Sanitizer	benzalkonium chloride
0363-0082	Hand wash	Benzalkonium chloride
0363-0651	Hand Wash	Benzalkonium chloride
0363-0683	Hand Wash	Benzalkonium chloride
0363-0644	Hand wipes	Benzalkonium chloride
0395-8010	HUMCO Merthiolate	Benzalkonium Chloride
0395-9122	Merthiolate	Benzalkonium Chloride
0363-0554	Nice	Benzalkonium chloride
0498-8043	North Safety First Aid Kit 019740-0027L/Z019740-0027L	Benzalkonium Chloride
0498-8046	North Safety First Aid Kit 019740-4526	Benzalkonium Chloride
0498-8048	North Safety First Aid Kit 019745-0032L	Benzalkonium Chloride
0498-8042	North Safety First Aid Kit 019746-0032L	Benzalkonium Chloride
0498-8047	North Safety First Aid Kit SF00002054	Benzalkonium Chloride
0498-8054	North Safety First Aid Kit SF00004415	Benzalkonium Chloride
0498-8053	North Safety First Aid Kit Z019846	Benzalkonium Chloride
0498-8051	North Safety First Aid Kit Z130023L	Benzalkonium Chloride
0295-9049	Stay Safe Hand Sanitizer Alcohol Free	benzalkonium chloride
0363-7215	STUDIO 35	BENZALKONIUM CHLORIDE
0363-7210	STUDIO 35 BEAUTY	BENZALKONIUM CHLORIDE
0363-0242	Walgreen	BENZALKONIUM CHLORIDE
0363-7211	Walgreens	BENZALKONIUM CHLORIDE
0363-9002	Walgreens Citrus Antibacterial Foaming Hand	Benzalkonium Chloride
0363-9000	Walgreens Fresh Antibacterial Foaming Hand	Benzalkonium Chloride