NDC 59428-500

Zapotol Dentidol Oral Analgesic

Benzocaine, And Benzalkonium Chloride

Zapotol Dentidol Oral Analgesic is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Productos Zapotol Corp.. The primary component is Benzocaine; Benzalkonium Chloride.

• Product ID: 59428-500_c8332db3-9bef-41d6-b5f7-2a8584f0ee7b
• NDC: 59428-500
• Product Type: Human Otc Drug
• Proprietary Name: Zapotol Dentidol Oral Analgesic
• Generic Name: Benzocaine, And Benzalkonium Chloride
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-05-18
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Productos Zapotol Corp.
• Substance Name: BENZOCAINE; BENZALKONIUM CHLORIDE
• Active Ingredient Strength: 20 g/100g; g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 59428-500-42

1 CARTON in 1 PACKAGE (59428-500-42) > 11.9 g in 1 CARTON

• Marketing Start Date: 2016-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59428-500-42 [59428050042]

Zapotol Dentidol Oral Analgesic GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-11-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	20 g/100g

OpenFDA Data

• SPL SET ID: 1368d8bd-4263-4d8f-8a44-20571a8d6f8c
• Manufacturer:
  • Productos Zapotol Corp.
• UNII:
  • F5UM2KM3W7
  • U3RSY48JW5
• RxNorm Concept Unique ID - RxCUI:
  • 1595155
• UPC Code:
  • 0647755018005

NDC Crossover Matching brand name "Zapotol Dentidol Oral Analgesic" or generic name "Benzocaine, And Benzalkonium Chloride"

NDC	Brand Name	Generic Name
59428-500	Zapotol Dentidol Oral Analgesic	Benzocaine, and Benzalkonium chloride
41250-782	Meijer Maximum Strength Oral Pain Relief	Benzocaine, and Benzalkonium Chloride