Maximum Strength Cold Sore Treatment

Product NDC: 72476-412
11-digit product format: 724760412
Labeler code: 72476
Product ID: 72476-412_632d77de-9792-40f9-a523-815088ee987f
Type: HUMAN OTC DRUG
Nonproprietary name: Maximum Strength Cold Sore Treatment
Dosage form: GEL
Route: TOPICAL
Labeler: Retail Business Services, LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-02-01
Marketing end: 0000-00-00
Substance: MENTHOL; PETROLATUM; CAMPHOR (SYNTHETIC); PHENOL
Active strength: 10 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	72476-412		D	Discontinued by firm		2026-10-05
excluded package	package	72476-412	72476-412-01	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	72476-412-01	`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	72476-412-01	`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
72476-412-01	2024-12-02	C162847	48780-1	1030e365-080b-111a-e063-dadaa90a10e2	Maximum Strength Cold Sore Treatment – Drug Facts
72476-412-01	2024-07-30	C162847	48780-1	1030e365-080b-111a-e063-dadaa90a10e2	Maximum Strength Cold Sore Treatment – Drug Facts
72476-412-01	2024-01-30	C162847	48780-1	1030e365-080b-111a-e063-dadaa90a10e2	Maximum Strength Cold Sore Treatment – Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72476-412	MAXIMUM STRENGTH COLD SORE TREATMENT GEL [RETAIL BUSINESS SERVICES, LLC]	3	Legacy NDC	20241204_9c476b0b-3534-2693-e053-2a95a90a26de.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72476-412-01	72476041201	2 g in 1 TUBE (72476-412-01)	2 g	2020-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Maximum Strength Cold Sore Treatment – Drug Facts	Retail Business Services, LLC	2024-12-02	HUMAN OTC DRUG LABEL	3