NDC 50438-303

Amber Mouth Rinse

Eucalyptol, Menthol, Methyl Salicylate, Thymol

Amber Mouth Rinse is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Filo America. The primary component is Eucalyptol; Menthol; Methyl Salicylate; Thymol.

• Product ID: 50438-303_3e53869c-ea36-4599-849f-ff629a1be9b7
• NDC: 50438-303
• Product Type: Human Otc Drug
• Proprietary Name: Amber Mouth Rinse
• Generic Name: Eucalyptol, Menthol, Methyl Salicylate, Thymol
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-30
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Filo America
• Substance Name: EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
• Active Ingredient Strength: 1 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50438-303-01

500 mL in 1 BOTTLE, PLASTIC (50438-303-01)

• Marketing Start Date: 2013-07-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50438-303-01 [50438030301]

Amber Mouth Rinse LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-07-30
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
EUCALYPTOL	.92 mg/mL

OpenFDA Data

• SPL SET ID: 45cd7964-2520-48f2-8155-35467b8f49f0
• Manufacturer:
  • Filo America
• UNII:
  • L7T10EIP3A
  • 3J50XA376E
  • RV6J6604TK
  • LAV5U5022Y
• RxNorm Concept Unique ID - RxCUI:
  • 1043619
• UPC Code:
  • 0793366200343

NDC Crossover Matching brand name "Amber Mouth Rinse" or generic name "Eucalyptol, Menthol, Methyl Salicylate, Thymol"

NDC	Brand Name	Generic Name
50438-303	Amber Mouth Rinse	Amber Mouth Rinse
0869-0072	Antiseptic	Eucalyptol, Menthol, Methyl salicylate, thymol
0869-0318	Antiseptic Mouth Rinse	EUCALYPTOL, Menthol, Methyl salicylate, Thymol
0363-0080	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
0363-0664	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
0869-0664	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
10202-664	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
11344-567	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
11673-072	Antispetic	Eucalyptol, menthol, methyl salicylate, thymol
0363-0318	Rinse	Eucalyptol, menthol, Methyl salicylate, thymol
0363-0045	Tartar Control Plus	eucalyptol, menthol, methyl salicylate, thymol
0363-0434	Tartar control plus	Eucalyptol, menthol, methyl salicylate, thymol
0363-0855	Tartar control plus	Eucalyptol, menthol, methyl salicylate, thymol
0869-0434	Tartar Control Plus	Eucalyptol, menthol, methyl salicylate, thymol
0869-0855	Tartar control plus	Eucalyptol, menthol, methyl salicylate, thymol