FDA.reportPublic FDA data

Methyl Salicylate

Product NDC
85231-201
11-digit product format
852310201
Labeler code
85231
Product ID
85231-201_39f7d92d-a262-c69a-e063-6394a90aca0f
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
ViolaCare, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-02
Substance
METHYL SALICYLATE
Active strength
25 g/60g
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
Methyl Salicylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE25 g/60g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238542Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f0ba6e7-8aa4-443e-99ae-a255085ddfecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-201-60Methyl Salicylate1 in 1 CARTONCREAM12
85231-201-60Methyl Salicylate60 g in 1 TUBECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-201-60GM - Gram85231-201ce5732a1-39bf-47bd-94ec-445aa6f0e44512025-09-12

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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238542methyl salicylate 25 % Topical CreamPSN8f0ba6e7-8aa4-443e-99ae-a255085ddfec2
238542methyl salicylate 250 MG/ML Topical CreamSCD8f0ba6e7-8aa4-443e-99ae-a255085ddfec2
238542methyl salicylate 25 % Topical CreamSY8f0ba6e7-8aa4-443e-99ae-a255085ddfec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85231-201-60852310201601 TUBE in 1 CARTON (85231-201-60) / 60 g in 1 TUBE1 tube2025-06-02NoNoCurrent