NDC 66969-6012

Oral Dent Amber

Eucalyptol ,thymol, Methyl Salicylate, Menthol

Oral Dent Amber is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by International Cosmetic Limited. The primary component is Eucalyptol; Thymol; Methyl Salicylate; Menthol.

• Product ID: 66969-6012_a861cd9a-2d37-4861-8270-d8c30bb91e7c
• NDC: 66969-6012
• Product Type: Human Otc Drug
• Proprietary Name: Oral Dent Amber
• Generic Name: Eucalyptol ,thymol, Methyl Salicylate, Menthol
• Dosage Form: Mouthwash
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-10
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: International Cosmetic Limited
• Substance Name: EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL
• Active Ingredient Strength: 0 g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 66969-6012-2

1000 mL in 1 BOTTLE (66969-6012-2)

• Marketing Start Date: 2013-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66969-6012-2 [66969601202]

Oral Dent Amber MOUTHWASH

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-01-10
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
EUCALYPTOL	.092 g/100mL

OpenFDA Data

• SPL SET ID: c03068f0-61a9-4be0-be42-a870491a39d7
• Manufacturer:
  • International Cosmetic Limited
• UNII:
  • 3J50XA376E
  • L7T10EIP3A
  • RV6J6604TK
  • LAV5U5022Y
• RxNorm Concept Unique ID - RxCUI:
  • 1043619

NDC Crossover Matching brand name "Oral Dent Amber" or generic name "Eucalyptol ,thymol, Methyl Salicylate, Menthol"

NDC	Brand Name	Generic Name
66969-6020	Oral Dent Amber	Oral Dent Amber
66969-6012	Oral Dent	Eucalyptol ,Thymol, Methyl Salicylate, Menthol