Valtrum Soothing Topical Analgesic

Product NDC: 75849-300
11-digit product format: 758490300
Labeler code: 75849
Product ID: 75849-300_b0617409-47b2-6e4c-e053-2995a90a721e
Type: HUMAN OTC DRUG
Nonproprietary name: CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Laboratorios Quantium LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-11-12
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength: 25 mg/g; mg/g; mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	75849-300		I	Inactivated by FDA		2026-10-05
excluded package	package	75849-300	75849-300-00	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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75849-300-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75849-300-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75849-300-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75849-300-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75849-300-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75849-300-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75849-300-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75849-300-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75849-300-00	`0efc9e666f02…`	`f202fb6c5f17…`
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	75849-300-00	`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	75849-300-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	75849-300-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	75849-300-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	75849-300-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	75849-300-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	75849-300-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	75849-300-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	75849-300-00	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-28	Valtrum Soothing Topical Analgesic Ointment
2020-09-28	Valtrum Soothing Topical Analgesic Ointment
2020-09-27	Valtrum Soothing Topical Analgesic Ointment
2020-09-25	Valtrum Soothing Topical Analgesic Ointment
2020-07-22	Valtrum Soothing Topical Analgesic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75849-300-00	Valtrum Soothing Topical Analgesic	90 g in 1 BOTTLE	OINTMENT	90		4
75849-300-00	Valtrum Soothing Topical Analgesic	1 in 1 CARTON	OINTMENT	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
GLUCOSAMINE	INACTIVE INGREDIENT	N08U5BOQ1K	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
HARPAGOPHYTUM PROCUMBENS ROOT	INACTIVE INGREDIENT	1OYM338E89	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75849-300	VALTRUM SOOTHING TOPICAL ANALGESIC (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [LABORATORIOS QUANTIUM LLC]	4	Legacy NDC, 2 package rows	20200929_bf7d00d1-901a-47e4-ada7-2e647a42304c.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
1721696	camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % Topical Ointment	PSN	bf7d00d1-901a-47e4-ada7-2e647a42304c	4
1721701	Valtrum Soothing 2.5 % / 2.5 % / 10 % Topical Ointment	PSN	bf7d00d1-901a-47e4-ada7-2e647a42304c	4
1721701	camphor 0.025 MG/MG / menthol 0.025 MG/MG / methyl salicylate 0.1 MG/MG Topical Ointment [Valtrum Soothing]	SBD	bf7d00d1-901a-47e4-ada7-2e647a42304c	4
1721696	camphor 0.025 MG/MG / menthol 0.025 MG/MG / methyl salicylate 0.1 MG/MG Topical Ointment	SCD	bf7d00d1-901a-47e4-ada7-2e647a42304c	4
1721696	camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % Topical Ointment	SY	bf7d00d1-901a-47e4-ada7-2e647a42304c	4
1721701	Valtrum Soothing (camphor 2.5 % / menthol 2.5 % / methyl salicylate 10 % ) Topical Ointment	SY	bf7d00d1-901a-47e4-ada7-2e647a42304c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75849-300-00	75849030000	1 BOTTLE in 1 CARTON (75849-300-00) > 90 g in 1 BOTTLE	1 bottle	2015-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Valtrum Soothing Topical Analgesic Ointment	Laboratorios Quantium LLC	2020-09-28	HUMAN OTC DRUG LABEL	4