Flexilon

Product NDC: 72826-101
Requested package NDC: 72826-101-14
11-digit product format: 728260101
Labeler code: 72826
Product ID: 72826-101_51c094e3-7a32-4f24-9944-5691c1e51e72
Type: HUMAN OTC DRUG
Nonproprietary name: methyl salicylate, menthol, camphor
Dosage form: CREAM
Route: TOPICAL
Labeler: Semprae Laboratories Inc
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-11-10
Marketing end: 0000-00-00
Substance: MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE
Active strength: 8 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	72826-101	72826-101-14	I	Inactivated by FDA		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
72826-101-14	2025-01-30	C162847	48780-1	d6a99b39-7f21-a426-e053-dadaa90af4c2	dba920f3-27c8-4f69-a524-f99e57a276a0
72826-101-14	2023-01-19	C162847	48780-1	d6a99b39-7f21-a426-e053-dadaa90af4c2	dba920f3-27c8-4f69-a524-f99e57a276a0
72826-101-14	2022-01-28	C162847	48780-1	d6a99b39-7f21-a426-e053-dadaa90af4c2	dba920f3-27c8-4f69-a524-f99e57a276a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72826-101-14	Flexilon	56.7 g in 1 CONTAINER	CREAM	56.7		2
72826-101-14	Flexilon	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72826-101	FLEXILON (METHYL SALICYLATE, MENTHOL, CAMPHOR) CREAM [SEMPRAE LABORATORIES INC]	2	Legacy NDC, 2 package rows	20230121_dba920f3-27c8-4f69-a524-f99e57a276a0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1998770	camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical Cream	PSN	dba920f3-27c8-4f69-a524-f99e57a276a0	2
1998770	camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	dba920f3-27c8-4f69-a524-f99e57a276a0	2
1998770	camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical Cream	SY	dba920f3-27c8-4f69-a524-f99e57a276a0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72826-101-14	72826010114	1 CONTAINER in 1 CARTON (72826-101-14) > 56.7 g in 1 CONTAINER	1 container	2020-11-10	0000-00-00	No	No	Current