FDA.reportPublic FDA data

MED O-3 BIO-

Product NDC
83538-101
11-digit product format
835380101
Labeler code
83538
Product ID
83538-101_0e49fac4-c072-beb0-e063-6294a90ac96f
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Biological M.D. Solutions LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-08
Substance
METHYL SALICYLATE; CAPSAICIN; MENTHOL
Active strength
10; .03; 1 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83538-101-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83538-101-18ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83538-101-180efc9e666f02…f202fb6c5f17…

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
MED O-3 BIO-
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE10 g/100mL
CAPSAICIN.03 g/100mL
MENTHOL1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2644111Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
02707552-03d9-3ad2-e063-6294a90a3472Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83538-101-182025-02-01C16284748780-12cef2736-898a-d83d-e063-dadaa90ab31fBIOLOGICAL MD SOLUTIONS (as PLD) - Med O-3 Bio-Cream (83538-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83538-101-18MED O-3 BIO-237 mL in 1 BOTTLECREAM2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83538-101MED O-3 BIO- (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [BIOLOGICAL M.D. SOLUTIONS LLC]2Current NDC, 1 package rows20250202_02707552-03d9-3ad2-e063-6294a90a3472.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 107 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
application number: M017
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMiramar Cosmetics, Inc DBA Miramar Laba6c4889c-e7a9-44b9-bd9a-70fd6e8c48252024-12-23WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONE 1%Trifecta Pharmaceuticals USA LLCaf5daf6c-bcad-8ebf-e053-2a95a90af1b02024-12-20WarningsExact identifier
application number: M017
Pain Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.44d3638d-f29b-0e01-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONERugby Laboratories132982ea-cce6-687c-e063-6294a90a46322024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLC9bb98452-a605-5c20-e053-2995a90a1ea72024-12-20WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 10.5%Derma Care Research Labs, LLC00dcdae0-c744-8402-e063-6294a90a12f82024-12-20WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Pharmacy Value Alliance LLCab95e606-69f0-1d58-e053-2a95a90a073b2024-12-20WarningsExact identifier
application number: M017
Itch Relief CreamZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%Pharmacy Value Alliance LLC37fe6d82-adee-4f58-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M017
Warrior First Aid Anti ItchDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCec6e9a5b-c61d-a385-e053-2995a90ac9362024-12-20WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE HCLDerma Care Research Labs, LLCff227154-cf3b-9796-e053-6294a90a55352024-12-20WarningsExact identifier
application number: M017
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE HCL 4%Meijerf31b11ed-2ff9-5cfc-e053-2a95a90af2ca2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefMENTHOL 10.5%Meijerbed81975-bd63-cf5b-e053-2995a90ac5fa2024-12-20WarningsExact identifier
application number: M017
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
application number: M017
Meijer Pain ReliefLIDOCAINE 4%Meijerbed67c31-c479-6f9b-e053-2a95a90a55162024-12-20WarningsExact identifier
application number: M017
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
application number: M017
Epsom SaltsMAGNESIUM SULFATEInternational Wholesale Inc.e4d9bc32-ac85-349f-e053-2995a90a032f2024-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644111capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical CreamPSN02707552-03d9-3ad2-e063-6294a90a34722
2644111capsaicin 0.3 MG/ML / menthol 10 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD02707552-03d9-3ad2-e063-6294a90a34722
2644111capsaicin 0.03 % / menthol 1 % / methyl salicylate 10 % Topical CreamSY02707552-03d9-3ad2-e063-6294a90a34722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83538-101-1883538010118237 mL in 1 BOTTLE (83538-101-18) 237 ml2023-08-08NoNoCurrent