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 90 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ef02d4-2ff5-cb23-e063-6294a90a68af2025-06-19WarningsExact identifier
application number: M017
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact 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