Rocainol TOPICAL ANALGESIC

Product NDC: 54312-825
11-digit product format: 543120825
Labeler code: 54312
Product ID: 54312-825_3998129b-973b-ecad-e063-6394a90acc89
Type: HUMAN OTC DRUG
Nonproprietary name: METHYL SALICYLATE, MENTHOL
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Compania Internacional de Comercio, S.A.P.I de C.V.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-30
Substance: METHYL SALICYLATE; MENTHOL
Active strength: 16; 8 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Rocainol TOPICAL ANALGESIC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	16 g/100g
MENTHOL	8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1306905	Internal RxNorm lookup
1306910	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
827ec7b2-3d87-47e0-a47a-966b25732c32	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54312-825-01	Rocainol TOPICAL ANALGESIC	1 in 1 PACKAGE	OINTMENT	1		10
54312-825-01	Rocainol TOPICAL ANALGESIC	45 g in 1 TUBE	OINTMENT	45		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
CETYL PHOSPHATE	INACTIVE INGREDIENT	VT07D6X67O	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54312-825	ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]	9	Current NDC, Legacy NDC, 2 package rows	20241218_827ec7b2-3d87-47e0-a47a-966b25732c32.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1306905	menthol 8 % / methyl salicylate 16 % Topical Ointment	PSN	827ec7b2-3d87-47e0-a47a-966b25732c32	10
1306910	Rocainol 8 % / 16 % Topical Ointment	PSN	827ec7b2-3d87-47e0-a47a-966b25732c32	10
1306910	menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment [Rocainol]	SBD	827ec7b2-3d87-47e0-a47a-966b25732c32	10
1306905	menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment	SCD	827ec7b2-3d87-47e0-a47a-966b25732c32	10
1306905	menthol 8 % / methyl salicylate 16 % Topical Ointment	SY	827ec7b2-3d87-47e0-a47a-966b25732c32	10
1306910	Rocainol (menthol 8 % / methyl salicylate 16 % ) Topical Ointment	SY	827ec7b2-3d87-47e0-a47a-966b25732c32	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54312-825-01	54312082501	1 TUBE in 1 PACKAGE (54312-825-01) / 45 g in 1 TUBE	1 tube	2019-05-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rocainol TOPICAL ANALGESIC OINTMENT	Compania Internacional de Comercio, S.A.P.I de C.V. \| Compania Internacional de Comercio, S.A.P.I. de C.V.	2025-07-10	HUMAN OTC DRUG LABEL	10