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 139 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017
Cool n HeatCOOL N HEATNeilMed Pharmaceuticals, Inc.a24cde17-280b-8358-e053-2a95a90af67d2024-01-11WarningsExact identifier
application number: M017
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
application number: M017
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
application number: M017
Cooling Itch ReliefCOOLING ITCH RELIEFNeilMed Pharmaceuticals, Inca24bdea0-18e8-8a5e-e053-2995a90acea22024-01-11WarningsExact identifier
application number: M017
Lightning X BurnLIDOCAINENantong Health & Beyond Hygienic Products Inc.0e69a971-0c6e-6ebe-e063-6394a90a0b332024-01-08WarningsExact identifier
application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
application number: M017
2nd CHANCE MOBILITY Pain ReliefHISTAMINE DIHYDROCHLORIDEALPHA NUTRITION, LLC575097ac-9fc9-4391-99d1-dff9b34817e32024-01-08WarningsExact identifier
application number: M017
Tiger Balm Arthritis RubCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.80932288-4797-40d3-aa8a-6af686fb67ad2024-01-08WarningsExact identifier
application number: M017
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
application number: M017
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
ndc (product): 83538-101
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact 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