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 41 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017
Maximum Strength Cortisone Cream with AloeHYDROCORTISONE CREAMCVS Pharmacyb95d30b0-6ebd-4989-a6ac-1a42e5d4aba52026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreens61b93226-10ff-43df-b1b6-bcea917a2f482026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact identifier
application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeadsMENTHOL, CAMPHORChattem, Inc.df5fd485-f583-46b7-a869-16ca2e17185c2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing CremeHYDROCORTISONEChattem, Inc.4b62615f-e713-42f2-8b9c-9eebf8d1b2702026-01-14WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsExact 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