NDC 36800-418

Topcare Cold Sore Treatment

Camphor, Menthol, Phenol, White Petrolatum

Topcare Cold Sore Treatment is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Camphor (synthetic); Menthol, Unspecified Form; Phenol; Petrolatum.

• Product ID: 36800-418_8aa20c71-0a9e-4de5-93ef-74a67fbff3bd
• NDC: 36800-418
• Product Type: Human Otc Drug
• Proprietary Name: Topcare Cold Sore Treatment
• Generic Name: Camphor, Menthol, Phenol, White Petrolatum
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2020-03-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333E
• Labeler Name: Topco Associates LLC
• Substance Name: CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL; PETROLATUM
• Active Ingredient Strength: 30 mg/g; mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 36800-418-01

1 TUBE in 1 PACKAGE (36800-418-01) > 2 g in 1 TUBE

• Marketing Start Date: 2020-03-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-418-01 [36800041801]

Topcare Cold Sore Treatment GEL

• Marketing Category: OTC monograph not final
• Application Number: part333E
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2020-03-09

Drug Details

Active Ingredients

Ingredient	Strength
CAMPHOR (SYNTHETIC)	30 mg/g

OpenFDA Data

• SPL SET ID: 8aa20c71-0a9e-4de5-93ef-74a67fbff3bd
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 5TJD82A1ET
  • 339NCG44TV
  • L7T10EIP3A
  • 4T6H12BN9U
• RxNorm Concept Unique ID - RxCUI:
  • 2175793

NDC Crossover Matching brand name "Topcare Cold Sore Treatment" or generic name "Camphor, Menthol, Phenol, White Petrolatum"

NDC	Brand Name	Generic Name
36800-407	TopCare Cold Sore Treatment	Camphor
36800-418	Topcare Cold Sore Treatment	camphor, menthol, phenol, white petrolatum
66923-000	Abridge Cold Sore Treatment	Camphor, Menthol, Phenol, White Petrolatum
41520-097	CareOne Cold Sore Treatment	camphor, menthol, phenol, white petrolatum
69842-695	Cold Sore Treatment	Camphor, Menthol, Phenol, White Petrolatum
55301-412	Exchange Select Cold Sore Treatment	Camphor, Menthol, Phenol, White Petrolatum
11673-412	Maximum Strength Cold Sore Treatment	camphor, menthol, phenol, white petrolatum
41250-411	Maximum Strength Cold Sore Treatment	Camphor, Menthol, Phenol, White Petrolatum
21130-418	Signature Care Maximum Strength Cold Sore Treatment	camphor, menthol, phenol, white petrolatum