NDC 61578-304

CTx4 Rinse Mint

Anticaries

CTx4 Rinse Mint is a Dental Rinse in the Human Otc Drug category. It is labeled and distributed by Oral Biotech. The primary component is Sodium Fluoride.

• Product ID: 61578-304_cbfdbbf7-06fb-418f-8e5e-35847dfb3e5c
• NDC: 61578-304
• Product Type: Human Otc Drug
• Proprietary Name: CTx4 Rinse Mint
• Generic Name: Anticaries
• Dosage Form: Rinse
• Route of Administration: DENTAL
• Marketing Start Date: 2012-05-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part355
• Labeler Name: Oral BioTech
• Substance Name: SODIUM FLUORIDE
• Active Ingredient Strength: 226 ug/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61578-304-01

2 BOTTLE, PLASTIC in 1 PACKAGE (61578-304-01) > 118 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2022-05-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61578-304-01 [61578030401]

CTx4 Rinse Mint RINSE

• Marketing Category: OTC monograph final
• Application Number: part355
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-05-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FLUORIDE	226 ug/mL

OpenFDA Data

• SPL SET ID: da4cf9be-34ef-4190-88ab-75600b57a773
• Manufacturer:
  • Oral BioTech
• UNII:
  • 8ZYQ1474W7
• RxNorm Concept Unique ID - RxCUI:
  • 240698
  • 1486532

NDC Crossover Matching brand name "CTx4 Rinse Mint" or generic name "Anticaries"

NDC	Brand Name	Generic Name
61578-301	CTx3 Rinse	Anticaries
61578-302	CTx3 Rinse	Anticaries
61578-303	CTx3 Rinse	Anticaries
61578-304	CTx4 Rinse	Anticaries
61578-305	CTx4 Rinse	Anticaries
61578-311	Maintenance Rinse	Anticaries
61578-312	Maintenance Rinse	Anticaries
61578-313	Maintenance Rinse	Anticaries
61578-314	Treatment Rinse	Anticaries
61578-315	Treatment Rinse	Anticaries