FDA.reportPublic FDA data

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
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE16 g/100g
MENTHOL8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
827ec7b2-3d87-47e0-a47a-966b25732c32Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54312-825-01Rocainol TOPICAL ANALGESIC1 in 1 PACKAGEOINTMENT110
54312-825-01Rocainol TOPICAL ANALGESIC45 g in 1 TUBEOINTMENT4510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
MENTHOLACTIVE MOIETYL7T10EIP3AROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67OROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
WATERINACTIVE INGREDIENT059QF0KO0RROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FROCAINOL 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
NDCDashboard titleSPL versionValidationDashboard ZIP
54312-825ROCAINOL TOPICAL ANALGESIC (METHYL SALICYLATE, MENTHOL) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.]9Current NDC, Legacy NDC, 2 package rows20241218_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 1 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1306905menthol 8 % / methyl salicylate 16 % Topical OintmentPSN827ec7b2-3d87-47e0-a47a-966b25732c3210
1306910Rocainol 8 % / 16 % Topical OintmentPSN827ec7b2-3d87-47e0-a47a-966b25732c3210
1306910menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment [Rocainol]SBD827ec7b2-3d87-47e0-a47a-966b25732c3210
1306905menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical OintmentSCD827ec7b2-3d87-47e0-a47a-966b25732c3210
1306905menthol 8 % / methyl salicylate 16 % Topical OintmentSY827ec7b2-3d87-47e0-a47a-966b25732c3210
1306910Rocainol (menthol 8 % / methyl salicylate 16 % ) Topical OintmentSY827ec7b2-3d87-47e0-a47a-966b25732c3210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54312-825-01543120825011 TUBE in 1 PACKAGE (54312-825-01) / 45 g in 1 TUBE1 tube2019-05-300000-00-00NoNoCurrent