FDA.reportPublic FDA data

MENTHOL AND METHYL SALICYLATE

Product NDC
63299-001
11-digit product format
632990001
Labeler code
63299
Product ID
63299-001_4344ef98-ce28-2cec-e063-6294a90a1c74
Type
HUMAN OTC DRUG
Nonproprietary name
ELECTRIC MEDICATED BALM ULTRA STRENGTH
Dosage form
OINTMENT
Route
TOPICAL
Labeler
FEI FAH MEDICAL MANUFACTURING PTE LTD
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-19
Marketing end
2029-11-22
Substance
MENTHOL; METHYL SALICYLATE
Active strength
16; 32 g/100g; g/100g
NDC exclude flag
No
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
MENTHOL AND METHYL SALICYLATE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL16 g/100g
METHYL SALICYLATE32 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2002730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91e6d3b9-25bb-4015-9d96-bd27f93e5adaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63299-001-01MENTHOL AND METHYL SALICYLATE1 in 1 BOXOINTMENT13
63299-001-01MENTHOL AND METHYL SALICYLATE70 g in 1 JAROINTMENT703
63299-001-02MENTHOL AND METHYL SALICYLATE10 g in 1 JAROINTMENT103
63299-001-02MENTHOL AND METHYL SALICYLATE1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63299-001MENTHOL AND METHYL SALICYLATE (ELECTRIC MEDICATED BALM ULTRA STRENGTH) OINTMENT [FEI FAH MEDICAL MANUFACTURING PTE LTD]2Current NDC, Legacy NDC, 4 package rows20241121_91e6d3b9-25bb-4015-9d96-bd27f93e5ada.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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002730menthol 16 % / methyl salicylate 32 % Topical OintmentPSN91e6d3b9-25bb-4015-9d96-bd27f93e5ada3
2002730menthol 0.16 MG/MG / methyl salicylate 0.32 MG/MG Topical OintmentSCD91e6d3b9-25bb-4015-9d96-bd27f93e5ada3
2002730menthol 16 % / methyl salicylate 32 % Topical OintmentSY91e6d3b9-25bb-4015-9d96-bd27f93e5ada3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63299-001-01632990001011 JAR in 1 BOX (63299-001-01) / 70 g in 1 JAR1 jar2024-10-192029-11-22NoNoCurrent
63299-001-02632990001021 JAR in 1 BOX (63299-001-02) / 10 g in 1 JAR1 jar2024-10-192029-11-22NoNoCurrent