NDC 10237-765

Orajel Denture Pain Relief

Benzocaine, Benzalkonium Chloride, Menthol

Orajel Denture Pain Relief is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Menthol; Benzocaine.

• Product ID: 10237-765_43cb4a9f-974f-4243-e054-00144ff8d46c
• NDC: 10237-765
• Product Type: Human Otc Drug
• Proprietary Name: Orajel Denture Pain Relief
• Generic Name: Benzocaine, Benzalkonium Chloride, Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-07-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Church & Dwight Co., Inc.
• Substance Name: MENTHOL; BENZOCAINE
• Active Ingredient Strength: 26 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10237-765-25

1 TUBE in 1 CARTON (10237-765-25) > 1 g in 1 TUBE

• Marketing Start Date: 2016-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-765-25 [10237076525]

Orajel Denture Pain Relief GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-07-01
• Marketing End Date: 2019-10-18

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	26 mg/g

OpenFDA Data

• SPL SET ID: 43cb4a9f-974e-4243-e054-00144ff8d46c
• Manufacturer:
  • Church & Dwight Co., Inc.
• UNII:
  • L7T10EIP3A
  • U3RSY48JW5

NDC Crossover Matching brand name "Orajel Denture Pain Relief" or generic name "Benzocaine, Benzalkonium Chloride, Menthol"

NDC	Brand Name	Generic Name
10237-765	Orajel Denture Pain Relief	Benzocaine, Benzalkonium Chloride, Menthol
10237-772	Orajel Denture Pain Relief	Benzocaine, Menthol, Zinc Chloride
10237-778	Orajel Denture Pain Relief	Benzocaine, Menthol, Zinc Chloride