NDC 10237-764

Orajel Toothache Rinse

Benzyl Alcohol, Zinc Chloride

Orajel Toothache Rinse is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzyl Alcohol; Zinc Chloride.

• Product ID: 10237-764_7f0a5726-2667-4412-e053-2991aa0a1ec2
• NDC: 10237-764
• Product Type: Human Otc Drug
• Proprietary Name: Orajel Toothache Rinse
• Generic Name: Benzyl Alcohol, Zinc Chloride
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-12-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Church & Dwight Co., Inc.
• Substance Name: BENZYL ALCOHOL; ZINC CHLORIDE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10237-764-08

236.6 mL in 1 BOTTLE (10237-764-08)

• Marketing Start Date: 2016-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-764-16 [10237076416]

Orajel Toothache Rinse LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-01

NDC 10237-764-08 [10237076408]

Orajel Toothache Rinse LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-12-24
• Marketing End Date: 2020-01-13

Drug Details

Active Ingredients

Ingredient	Strength
BENZYL ALCOHOL	2.91 mg/mL

OpenFDA Data

• SPL SET ID: 41709710-5392-3119-e054-00144ff88e88
• Manufacturer:
  • Church & Dwight Co., Inc.
• UNII:
  • LKG8494WBH
  • 86Q357L16B
• RxNorm Concept Unique ID - RxCUI:
  • 1865199
  • 1865204

NDC Crossover Matching brand name "Orajel Toothache Rinse" or generic name "Benzyl Alcohol, Zinc Chloride"

NDC	Brand Name	Generic Name
10237-764	Orajel Toothache Rinse	Benzyl Alcohol, Zinc Chloride
62864-764	Orajel Toothache Rinse	Benzyl Alcohol, Zinc Chloride