NDC 71416-001

Protocoxil

Benzyl Alcohol

Protocoxil is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Bio. The primary component is Benzyl Alcohol.

• Product ID: 71416-001_7be8b8f2-80bc-46e1-e053-2a91aa0ac2d2
• NDC: 71416-001
• Product Type: Human Otc Drug
• Proprietary Name: Protocoxil
• Generic Name: Benzyl Alcohol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-05-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Bio
• Substance Name: BENZYL ALCOHOL
• Active Ingredient Strength: 100 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71416-001-01

45 g in 1 BOTTLE (71416-001-01)

• Marketing Start Date: 2017-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71416-001-01 [71416000101]

Protocoxil GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-05-09
• Marketing End Date: 2021-10-07

NDC 71416-001-00 [71416000100]

Protocoxil GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-05-09
• Marketing End Date: 2019-10-07

Drug Details

Active Ingredients

Ingredient	Strength
BENZYL ALCOHOL	100 mg/g

OpenFDA Data

• SPL SET ID: 0612d4de-1c47-47fe-9a90-9ff6a8f3db0e
• Manufacturer:
  • BioEkuiliberLLC
• UNII:
  • LKG8494WBH
• RxNorm Concept Unique ID - RxCUI:
  • 247308

NDC Crossover Matching brand name "Protocoxil" or generic name "Benzyl Alcohol"

NDC	Brand Name	Generic Name
71416-001	Protocoxil	BENZYL ALCOHOL
54866-002	AVERTEAX	Benzyl Alcohol
23594-780	Ulesfia	benzyl alcohol
69202-780	Ulesfia	benzyl alcohol
50486-468	Zilactin	benzyl alcohol
72751-0301	Zilactin	benzyl alcohol