NDC 10237-708

Orajel Instant Pain Relief Maximum Strength

Benzocaine

Orajel Instant Pain Relief Maximum Strength is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzalkonium Chloride; Benzocaine; Zinc Chloride.

• Product ID: 10237-708_2334b033-51b1-4f69-921d-d546aaf3638a
• NDC: 10237-708
• Product Type: Human Otc Drug
• Proprietary Name: Orajel Instant Pain Relief Maximum Strength
• Generic Name: Benzocaine
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-06-11
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Church & Dwight Co., Inc.
• Substance Name: BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE
• Active Ingredient Strength: 0 mg/g; mg/g; mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 10237-708-12

1 TUBE in 1 CARTON (10237-708-12) > 3.5 g in 1 TUBE

• Marketing Start Date: 2010-06-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-708-42 [10237070842]

Orajel Instant Pain Relief Maximum Strength GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-06-11
• Inactivation Date: 2020-01-31

NDC 10237-708-12 [10237070812]

Orajel Instant Pain Relief Maximum Strength GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-03-20
• Inactivation Date: 2020-01-31

NDC 10237-708-18 [10237070818]

Orajel Instant Pain Relief Maximum Strength GEL

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-06-11
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZALKONIUM CHLORIDE	.4 mg/g

OpenFDA Data

• SPL SET ID: 1463de61-91ba-4bac-a43a-f0d7ceeee0d0
• Manufacturer:
  • Church & Dwight Co., Inc.
• UNII:
  • F5UM2KM3W7
  • U3RSY48JW5
  • 86Q357L16B

NDC Crossover Matching brand name "Orajel Instant Pain Relief Maximum Strength" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
10237-708	Orajel Instant Pain Relief Maximum Strength	Orajel Instant Pain Relief Maximum Strength
0283-0220	HurriCaine	Benzocaine
0283-0293	HurriCaine	Benzocaine
0283-0520	HurriCaine	Benzocaine
0283-0569	HurriCaine	Benzocaine
0283-0679	HurriCaine	Benzocaine
0283-0871	HurriCaine	BENZOCAINE
0283-0886	HurriCaine	Benzocaine
0283-0914	HurriCaine	Benzocaine
0283-0920	HurriCaine	Benzocaine
0283-0998	HurriCaine	Benzocaine
0283-1016	HurriCaine	BENZOCAINE