NDC 10237-747

Orajel Instant Pain Relief Severe

Benzocaine 20%, Menthol, Benzalkonium Chloride

Orajel Instant Pain Relief Severe is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Church Dwight Co., Inc.. The primary component is Benzocaine; Benzalkonium Chloride; Menthol.

• Product ID: 10237-747_4c6ea515-ad26-3d66-e054-00144ff8d46c
• NDC: 10237-747
• Product Type: Human Otc Drug
• Proprietary Name: Orajel Instant Pain Relief Severe
• Generic Name: Benzocaine 20%, Menthol, Benzalkonium Chloride
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-02-27
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Church Dwight Co., Inc.
• Substance Name: BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL
• Active Ingredient Strength: 200 mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10237-747-32

1 TUBE in 1 CARTON (10237-747-32) > 9.4 g in 1 TUBE

• Marketing Start Date: 2017-02-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-747-25 [10237074725]

Orajel Instant Pain Relief Severe CREAM

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-27
• Marketing End Date: 2017-02-27

NDC 10237-747-32 [10237074732]

Orajel Instant Pain Relief Severe CREAM

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-27
• Inactivation Date: 2020-01-31

NDC 10237-747-33 [10237074733]

Orajel Instant Pain Relief Severe CREAM

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-02-17
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	200 mg/g

OpenFDA Data

• SPL SET ID: 4ce932f7-46fd-2caf-e054-00144ff88e88
• Manufacturer:
  • Church Dwight Co., Inc.
• UNII:
  • F5UM2KM3W7
  • U3RSY48JW5
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1483194
  • 1483199

NDC Crossover Matching brand name "Orajel Instant Pain Relief Severe" or generic name "Benzocaine 20%, Menthol, Benzalkonium Chloride"

NDC	Brand Name	Generic Name
10237-753	Orajel Instant Pain Relief SEVERE	Orajel Instant Pain Relief SEVERE
10237-766	Benzocaine, Menthol, Zinc Chloride	Orajel Instant Pain Relief Severe
10237-768	Benzocaine, Menthol, Zinc Chloride	Orajel Instant Pain Relief Severe
10237-769	Benzocaine, Menthol, Zinc Chloride	Orajel Instant Pain Relief Severe
10237-770	Benzocaine, Menthol, Zinc Chloride	Orajel Instant Pain Relief Severe
10237-747	Orajel Instant Pain Relief	Benzocaine 20%, Menthol, Benzalkonium Chloride
10237-748	Orajel Instant Pain Relief	Benzocaine 20%, Menthol, Benzalkonium Chloride
10237-752	Orajel Instant Pain Relief	Benzocaine 20%, Menthol, Benzalkonium Chloride