FDA.reportPublic FDA data

Ubredol

Product NDC
55758-377
11-digit product format
557580377
Labeler code
55758
Product ID
55758-377_5de41c46-5644-2a19-e063-6394a90a66cf
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-20
Substance
METHYL SALICYLATE
Active strength
10 g/100g
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
Ubredol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-377-03Ubredol85 g in 1 JAROINTMENT854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-377UBREDOL (METHYL SALICYLATE) OINTMENT [PHARMADEL LLC]2Current NDC, 1 package rows20241121_fe96eead-1722-c05d-e053-6394a90a850f.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 39 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact identifier
application number: M017
Black Cobra Tattoo Numbing Cream 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605961a-d596-9c4a-e063-6394a90a99dc2026-01-19WarningsExact identifier
application number: M017
Bakers Best Arthritis Pain ReliefHISTAMINE DIHYDROCHLORIDEBaker's Best Health Products, LLC869735f9-335e-4a5e-adfc-91167ae943c52026-01-19WarningsExact identifier
application number: M017
SIMPLY VITAL PAIN RELIEF HEMPMENTHOLALPHA PLANTS INCc14f4c06-cfe5-497e-9f9e-b2ba442e61bb2026-01-19WarningsExact identifier
application number: M017
AsperFlexMENTHOL AND METHYL SALICYLATEAkron Pharma Inc.117de175-976d-44f3-85ed-3d127fbe3a7c2026-01-19WarningsExact identifier
application number: M017
Equate Pain Relieving Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATEWal-Mart Stores Inc5ed1d7b3-925e-4a18-8e15-636f5b442ad72026-01-19WarningsExact identifier
application number: M017
Equate Medicated Pain Relieving Patch, Large 6-CountCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Inc2c25cd7a-7e7b-5add-e063-6294a90a9e9b2026-01-19WarningsExact identifier
application number: M017
Equate Hydrocortione1% HYDROCORTISONEWalmart Inc.85b7f620-cc95-4333-b124-bbcc8fd5f7eb2026-01-19WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOLGURUNANDA, LLC3f1d146e-0d18-7f2f-e063-6394a90ab8162026-01-19WarningsExact identifier
application number: M017
Aspercreme with LidocaineLIDOCAINEChattem, Inc.7ad8efa9-7031-4cd0-be1d-6dee63091fd12026-01-19WarningsExact identifier
application number: M017
Best Choice Targeted Warming Capsaicin Heat PatchCAPSAICINValu Merchandisers Company24ca40b7-e17b-42a3-bcc8-6861b9a5934a2026-01-18WarningsExact identifier
application number: M017
TOPCARE PAIN RELIEF PATCHESLIDOCAINETOPCO ASSOCIATES, LLCfa2f7768-e779-4409-aad3-6c33ce2e6b362026-01-18WarningsExact identifier
application number: M017
Neuropathy Pain Relief CreamMENTHOL CREAMOwell Naturals Brand, LLC48979093-2992-5fd8-e063-6394a90a815d2026-01-17WarningsExact identifier
application number: M017
CVS Lidocaine Pain Relief CreamLIDOCAINE HYDROCHLORIDECVS Pharmacy45c4f946-13b9-7a0a-e063-6394a90a73532026-01-16WarningsExact identifier
application number: M017
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
application number: M017
CalmaraCALMARADynarex Corporation487393e9-6619-6033-e063-6294a90a68b22026-01-16WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTWalgreens7088092c-3a5f-4fcc-84cc-931d238f75012026-01-15WarningsExact identifier
application number: M017
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
application number: M017
Walgreen Itch Relief GelDIPHENHYDRAMINE HYDROCHLORIDEWalgreens5aca3297-406f-4165-9895-c58ccffb374f2026-01-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2536330methyl salicylate 10 % Topical OintmentPSNfe96eead-1722-c05d-e053-6394a90a850f4
2536330methyl salicylate 0.1 MG/MG Topical OintmentSCDfe96eead-1722-c05d-e053-6394a90a850f4
2536330methyl salicylate 10 % Topical OintmentSYfe96eead-1722-c05d-e053-6394a90a850f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-377-035575803770385 g in 1 JAR (55758-377-03) 85 g2023-06-20NoNoCurrent