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 49 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
application number: M017
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEHarris Teeter5a0501e8-bc06-4e33-8db8-93b21a7151412025-12-29WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLHarris Teeter9debd4ef-c21b-41ae-afd1-58f47c51c99c2025-12-29WarningsExact identifier
application number: M017
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact 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