NDC 71927-006

Mouthwash

Menthol, Methyl Salicylate, Thymol

Mouthwash is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Orazen Inc. The primary component is Methyl Salicylate; Thymol; Eucalyptol; Menthol.

• Product ID: 71927-006_873c2601-931a-b87b-e053-2991aa0aea7a
• NDC: 71927-006
• Product Type: Human Otc Drug
• Proprietary Name: Mouthwash
• Generic Name: Menthol, Methyl Salicylate, Thymol
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-22
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Orazen Inc
• Substance Name: METHYL SALICYLATE; THYMOL; EUCALYPTOL; MENTHOL
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71927-006-01

251 mL in 1 BOTTLE (71927-006-01)

• Marketing Start Date: 2019-04-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71927-006-01 [71927000601]

Mouthwash LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-22

Drug Details

Active Ingredients

Ingredient	Strength
METHYL SALICYLATE	.6 mg/mL

OpenFDA Data

• SPL SET ID: 873c43df-1d46-359b-e053-2a91aa0a4319
• Manufacturer:
  • Orazen Inc
• UNII:
  • 3J50XA376E
  • L7T10EIP3A
  • RV6J6604TK
  • LAV5U5022Y

NDC Crossover Matching brand name "Mouthwash" or generic name "Menthol, Methyl Salicylate, Thymol"

NDC	Brand Name	Generic Name
51414-105	Mouthwash	Cetylpyridinium chloride
53943-514	Mouthwash	Eucalyptol, Menthol, Methyl Salicylate, Thymol
71927-006	Mouthwash	Menthol, Methyl salicylate, Thymol
43493-0005	Kalaya Breath Refresh	Mouthwash