Topcare Cold Sore Treatment

Product NDC: 36800-418
11-digit product format: 368000418
Labeler code: 36800
Product ID: 36800-418_fac8e2d9-99c6-47c0-b293-8f2e1f82c8d9
Type: HUMAN OTC DRUG
Nonproprietary name: camphor, menthol, phenol, white petrolatum
Dosage form: GEL
Route: TOPICAL
Labeler: Topco Associates LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-09
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL; PETROLATUM
Active strength: 30 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	36800-418		D	Discontinued by firm		2026-10-05
excluded package	package	36800-418	36800-418-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-418-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-418-01	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-418-01	2024-12-27	C162847	48780-1	1030e365-2b33-111a-e063-dadaa90a10e2	Topco Associates LLC. Cold Sore Treatment Drug Facts
36800-418-01	2024-07-30	C162847	48780-1	1030e365-2b33-111a-e063-dadaa90a10e2	Topco Associates LLC. Cold Sore Treatment Drug Facts
36800-418-01	2024-01-30	C162847	48780-1	1030e365-2b33-111a-e063-dadaa90a10e2	Topco Associates LLC. Cold Sore Treatment Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-418	TOPCARE COLD SORE TREATMENT (CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM) GEL [TOPCO ASSOCIATES LLC]	3	Legacy NDC	20241228_8aa20c71-0a9e-4de5-93ef-74a67fbff3bd.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
339NCG44TV	PHENOL	108-95-2	PHENOL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-418-01	36800041801	1 TUBE in 1 PACKAGE (36800-418-01) > 2 g in 1 TUBE	1 tube	2020-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Cold Sore Treatment Drug Facts	Topco Associates LLC	2024-11-27	HUMAN OTC DRUG LABEL	3