NDC 10237-748

Orajel Instant Pain Relief Severe PM

Benzocaine 20%, Menthol, Benzalkonium Chloride

Orajel Instant Pain Relief Severe PM 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: 10237-748_319151fb-fce6-4103-8301-f8e4dabc2543
• NDC: 10237-748
• Product Type: Human Otc Drug
• Proprietary Name: Orajel Instant Pain Relief Severe PM
• Generic Name: Benzocaine 20%, Menthol, Benzalkonium Chloride
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-12-01
• 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 10237-748-25

1 TUBE in 1 CARTON (10237-748-25) > 7 g in 1 TUBE

• Marketing Start Date: 2013-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10237-748-25 [10237074825]

Orajel Instant Pain Relief Severe PM CREAM

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-12-01
• Marketing End Date: 2019-12-20

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	200 mg/g

OpenFDA Data

• SPL SET ID: 0a12878c-7808-4c0e-aeb0-6954d1dee404
• 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 PM" or generic name "Benzocaine 20%, Menthol, Benzalkonium Chloride"

NDC	Brand Name	Generic Name
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