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
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
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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact 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