Valtrum Analgesic

Product NDC: 75849-312
Requested package NDC: 75849-312-03
11-digit product format: 758490312
Labeler code: 75849
Product ID: 75849-312_c9ed6773-b657-720c-e053-2a95a90ae2b1
Type: HUMAN OTC DRUG
Nonproprietary name: CAMPHOR (SYNTHETIC), MENTHOL, MENTHYL SALICYLATE
Dosage form: GEL
Route: TOPICAL
Labeler: Laboratorios Quantium LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-07-15
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)-
Active strength: 30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	75849-312	75849-312-03	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
75849-312-03	2023-01-30	C162847	48780-1	f386c649-d7d1-0266-e053-dadaa90a7c1a	Valtrum Topical Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75849-312-03	Valtrum Analgesic	90 g in 1 TUBE	GEL	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75849-312	VALTRUM ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, MENTHYL SALICYLATE) GEL [LABORATORIOS QUANTIUM LLC]	3	Legacy NDC, 1 package rows	20210820_c72e768c-d1ee-ba0b-e053-2a95a90a5f99.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
43XOA705ZD	MENTHYL SALICYLATE, (+/-)-	89-46-3	MENTHYL SALICYLATE, (+/-)-

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2123377	camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical Gel	PSN	c72e768c-d1ee-ba0b-e053-2a95a90a5f99	3
2123377	camphor 0.03 MG/MG / menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Topical Gel	SCD	c72e768c-d1ee-ba0b-e053-2a95a90a5f99	3
2123377	camphor 3 % / menthol 3 % / methyl salicylate 10 % Topical Gel	SY	c72e768c-d1ee-ba0b-e053-2a95a90a5f99	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75849-312-03	75849031203	90 g in 1 TUBE (75849-312-03)	90 g	2021-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valtrum Topical Analgesic Gel	Laboratorios Quantium LLC \| GADAL Laboratories, Inc	2021-08-19	HUMAN OTC DRUG LABEL	3