OWELL NATURALS Deep Penetrating Pain Relief

Product NDC
83570-443
11-digit product format
835700443
Labeler code
83570
Product ID
83570-443_0dba3e8a-1315-7ab3-e063-6394a90a8a6a
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
OWELL NATURALS BRAND, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-08
Substance
MENTHOL
Active strength
76.6 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
OWELL NATURALS Deep Penetrating Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL76.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2672826Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b36eb017-ed8d-476e-994b-22b275e00543Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83570-443-02OWELL NATURALS Deep Penetrating Pain Relief60 mL in 1 JAROINTMENT601
83570-443-03OWELL NATURALS Deep Penetrating Pain Relief103.5 mL in 1 JAROINTMENT103.51
83570-443-07OWELL NATURALS Deep Penetrating Pain Relief207 mL in 1 JAROINTMENT2071
83570-443-14OWELL NATURALS Deep Penetrating Pain Relief414 mL in 1 JAROINTMENT4141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83570-443OWELL NATURALS DEEP PENETRATING PAIN RELIEF (MENTHOL) OINTMENT [OWELL NATURALS BRAND, LLC]1Current NDC, 4 package rows20240108_b36eb017-ed8d-476e-994b-22b275e00543.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 50 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEAhold U.S.A., Inc,7e7a813e-424d-4a78-9c72-541c3c62606a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Cold and Hot Medicated PatchMENTHOLAmazon.com Services LLCe3b4db12-c846-b984-e053-2a95a90a8e9a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Pain Relief Patch with 4% LidocaineLIDOCAINEAmazon.com Services LLCe3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e2025-12-28WarningsExact identifier
application number: M017
Absorbine Jr Neck and ShoulderABSORBINE JR NECK AND SHOULDERClarion Brands LLC22f2f191-9146-3075-e063-6394a90aef5f2025-12-28WarningsExact identifier
application number: M017
Absorbine Jr. Pain Relieving Knee PatchABSORBINE JR. PAIN RELIEVING KNEE PATCHClarion Brands, LLC22f71254-e521-2d82-e063-6394a90a12d82025-12-28WarningsExact identifier
application number: M017
Absorbine Jr Back PatchABSORBINE JR BACK PATCHClarion Brands LLC.22f5147e-ff2b-4ae8-e063-6394a90a4e542025-12-28WarningsExact identifier
application number: M017
Absorbine Jr. Pro RollonABSORBINE JR. PRO ROLLONClarion Brands, LLC470efcd0-d350-3dc4-e063-6394a90ab8c12025-12-28WarningsExact identifier
application number: M017
Med Rub BalmACHES AND PAIN BALMWellmetech Pharmaceutical Industries SDN BHDa5801566-6bbe-44f6-8761-9c1ce30969002025-12-27WarningsExact identifier
application number: M017
N-Labs ArcticZen Pain Relief KneeCAMPHOR (SYNTHETIC), MENTHOLNutriomo Labs PTE., LTD46e92db7-a48b-2c7a-e063-6394a90a438e2025-12-27WarningsExact identifier
application number: M017
Absorbine Jr. PlusMENTHOLClarion Brands, LLC46f4ad3c-7418-a6bf-e063-6394a90a4eb82025-12-27WarningsExact identifier
application number: M017
Equate Lidocaine Cool and HeatLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Incb86769c3-a0b4-c481-e053-2a95a90af38b2025-12-27WarningsExact identifier
application number: M017
Medicated Body Extra Strength PowderMENTHOL 0.80%Walmart Stores Incb0786418-7b28-d316-e053-2995a90a3ab52025-12-27WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMEDICATED FOOT POWDERWalmart Stores Incb0794d48-eb8b-55c9-e053-2995a90a5b382025-12-27WarningsExact identifier
application number: M017
Walgreens 24-Hour Lidocaine PatchLIDOCAINE 4%Walgreens Companyb8402924-b5fc-0acd-e053-2a95a90a18052025-12-27WarningsExact identifier
application number: M017
Frankincense and Myrrh Foot Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.115f1abc-34aa-3c20-e063-6294a90a97642025-12-26WarningsExact identifier
application number: M017
Soothing Nerve ReliefMENTHOLWise Consumer Products46e23c95-1a36-214e-e063-6394a90a98a82025-12-26WarningsExact identifier
application number: M017
Frankincense and Myrrh Foot Pain Relief Combo PackMENTHOLWISE CONSUMER PRODUCTS CO.46e2c8b6-bd94-7100-e063-6294a90ac9982025-12-26WarningsExact identifier
application number: M017
Pain Patch Perfecto 24 Hours Lidocaine 4 % PatchLIDOCAINEPainpatchperfecto LLCa281c3e9-1c48-4905-98cc-3cedf6042adc2025-12-25WarningsExact identifier
application number: M017
Aloe UP SPF 33 MineralZINC OXIDEAloe Care International, LLC35aa6196-682d-8f32-e063-6394a90aad992025-12-24WarningsExact identifier
application number: M017
ETADERM Numbing CreamLIDOCAINENUEPHASE LLC5292c6ff-b878-4e71-878b-4bf08207612e2025-12-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672826menthol 7.66 % Topical OintmentPSNb36eb017-ed8d-476e-994b-22b275e005431
2672826menthol 0.0766 MG/MG Topical OintmentSCDb36eb017-ed8d-476e-994b-22b275e005431
2672826menthol 7.66 % Topical OintmentSYb36eb017-ed8d-476e-994b-22b275e005431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83570-443-028357004430260 mL in 1 JAR (83570-443-02) 60 ml2024-01-08NoNoCurrent
83570-443-0383570044303103.5 mL in 1 JAR (83570-443-03) 103.5 ml2024-01-08NoNoCurrent
83570-443-0783570044307207 mL in 1 JAR (83570-443-07) 207 ml2024-01-08NoNoCurrent
83570-443-1483570044314414 mL in 1 JAR (83570-443-14) 414 ml2024-01-08NoNoCurrent