FDA.reportPublic FDA data

Methyl Salicylate

Product NDC
79643-004
11-digit product format
796430004
Labeler code
79643
Product ID
79643-004_5d6c885d-8d55-738a-e063-6394a90a074e
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
PHARMACURE LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-01
Substance
METHYL SALICYLATE
Active strength
250 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE250 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-004-01Methyl Salicylate100 g in 1 TUBECREAM1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-004-01GM - Gram79643-00462ec9c0d-58f9-424c-9d58-27a407b639b012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-004METHYL SALICYLATE CREAM [PHARMACURE LLC]2Current NDC, 1 package rows20240524_f119a1bd-095f-41f5-86d5-c0ee4f19fd2c.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 133 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238542methyl salicylate 25 % Topical CreamPSNf119a1bd-095f-41f5-86d5-c0ee4f19fd2c3
238542methyl salicylate 250 MG/ML Topical CreamSCDf119a1bd-095f-41f5-86d5-c0ee4f19fd2c3
238542methyl salicylate 25 % Topical CreamSYf119a1bd-095f-41f5-86d5-c0ee4f19fd2c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79643-004-0179643000401100 g in 1 TUBE (79643-004-01) 100 g2024-05-01NoNoCurrent