NDC 54859-503

Orasep

Benzocaine, Menthol, Cetylpyridinium Chloride

Orasep is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Benzocaine; Menthol; Cetylpyridinium Chloride.

• Product ID: 54859-503_0d736755-babb-4ec8-8a9a-c92010578881
• NDC: 54859-503
• Product Type: Human Otc Drug
• Proprietary Name: Orasep
• Generic Name: Benzocaine, Menthol, Cetylpyridinium Chloride
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Llorens Pharmaceutical International Division
• Substance Name: BENZOCAINE; MENTHOL; CETYLPYRIDINIUM CHLORIDE
• Active Ingredient Strength: 2 mg/100mL; mg/100mL; mg/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54859-503-01

30 mL in 1 BOTTLE (54859-503-01)

• Marketing Start Date: 2010-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54859-503-01 [54859050301]

Orasep LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-04-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	2 mg/100mL

OpenFDA Data

• SPL SET ID: ed70911b-9da8-4e1d-97fa-66b18d28516a
• Manufacturer:
  • Llorens Pharmaceutical International Division
• UNII:
  • U3RSY48JW5
  • L7T10EIP3A
  • D9OM4SK49P
• RxNorm Concept Unique ID - RxCUI:
  • 1547767
  • 1362704

NDC Crossover Matching brand name "Orasep" or generic name "Benzocaine, Menthol, Cetylpyridinium Chloride"

NDC	Brand Name	Generic Name
54859-503	Orasep	Benzocaine, Menthol, Cetylpyridinium Chloride
54859-504	Orasep	Benzocaine, Menthol, Cetylpyridinium Chloride
63102-106	ACTISEP	BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE
63102-107	ACTISEP	BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE