FDA.reportPublic FDA data

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 68 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
application number: M017
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
application number: M017
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
application number: M017
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
application number: M017
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINE AND MENTHOLBullet point LLC42c70681-494b-47c9-e063-6394a90a80be2025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLCba6c7e97-d740-484b-8711-55fa7ab157842025-11-04WarningsExact identifier
application number: M017
China-GelMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, Inc.d7c5cb17-f7a2-7f57-e053-2995a90a40f72025-11-04WarningsExact identifier
application number: M017
Aulief Topical Pain RelieverMENTHOL AND CAMOHORChina-Gel, LLC8647dcc3-1dbc-1093-e053-2991aa0a1ab92025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLC254abae9-ef1b-5a90-e054-00144ff88e882025-11-04WarningsExact identifier
application number: M017
Pain Relief Gel-TubeMENTHOLBullet point LLC42c93789-9758-54b7-e063-6394a90ac3982025-11-04WarningsExact identifier
application number: M017
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
application number: M017
CORE RELIEFCAMPHOR, MENTHOLCopper Joint, LLC42d17270-f58d-9d69-e063-6294a90a40782025-11-04WarningsExact identifier
application number: M017
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
application number: M017
Goodsense Extra Strength Cold and Hot MedicatedMENTHOLGeiss, Destin and Dunn, Inc.7585d111-775f-4fb6-a485-28cd99d888522025-10-31WarningsExact 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