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 103 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact 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