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 121 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Maximum Strength Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLCdc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab2024-11-05WarningsExact identifier
application number: M017
Aveeno Restorative Skin Therapy Itch Relief BalmPRAMOXINE HYDROCHLORIDEKenvue Brands LLC61824ca7-a2d3-4830-b2bb-149a3222bfc82024-11-05WarningsExact identifier
application number: M017
Aveeno Hydrocortisone ANTI-ITCHHYDROCORTISONEKenvue Brands LLC233de4d7-e533-40cd-a5ed-e8b09abc626e2024-11-05WarningsExact identifier
application number: M017
STING MASTERLIDOCAINE HYDROCHLORIDELes Technologies Ptero, Inc94c6fd1f-9e74-420b-9d25-61b37953b8382024-11-05WarningsExact identifier
application number: M017
Alocane Emergency BurnLIDOCAINE HYDROCHLORIDEQuest Products, LLC.0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEBorden Company (Private) Limiteded79f14e-6b3d-4bf2-9c34-d019c1ba25822024-11-04WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEA-S Medication Solutions3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e32024-11-04WarningsExact identifier
application number: M017
Walgreens Ice Blue Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMWalgreen Company1c0ee442-ffd2-4f6c-aab2-f70e295378ad2024-11-04WarningsExact identifier
application number: M017
Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORMWalgreen Companyd5c79476-dde8-4a85-8878-bc2ac3a3d70b2024-11-04WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINESTRATUS PHARMACEUTICALS INC87a4f559-a4f6-4b9f-98de-b55b073a11c62024-11-01WarningsExact identifier
application number: M017
Walgreens Nerve Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMWalgreen Company83849eca-e02f-4b43-b3a7-b25e987e08a82024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica WhiteCAMPHORSanvall Enterprises, Inc192039a2-aed6-821b-e063-6394a90a7f292024-10-31WarningsExact 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