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
Ingredient	Strength
MENTHOL	76.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b36eb017-ed8d-476e-994b-22b275e00543	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
83570-443-02	OWELL NATURALS Deep Penetrating Pain Relief	60 mL in 1 JAR	OINTMENT	60	1
83570-443-03	OWELL NATURALS Deep Penetrating Pain Relief	103.5 mL in 1 JAR	OINTMENT	103.5	1
83570-443-07	OWELL NATURALS Deep Penetrating Pain Relief	207 mL in 1 JAR	OINTMENT	207	1
83570-443-14	OWELL NATURALS Deep Penetrating Pain Relief	414 mL in 1 JAR	OINTMENT	414	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83570-443	OWELL NATURALS DEEP PENETRATING PAIN RELIEF (MENTHOL) OINTMENT [OWELL NATURALS BRAND, LLC]	1	Current NDC, 4 package rows	20240108_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 106 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Itch Relief	LIDOCAINE HCI	Trifecta Pharmaceutical USA LLC	f40b19a8-795c-f514-e053-2a95a90a6d15	2024-12-20	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Rugby Laboratories	132982ea-cce6-687c-e063-6294a90a4632	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	9bb98452-a605-5c20-e053-2995a90a1ea7	2024-12-20	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Exact identifier application number: M017
Itch Relief Cream	ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%	Pharmacy Value Alliance LLC	37fe6d82-adee-4f58-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Warrior First Aid Anti Itch	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	ec6e9a5b-c61d-a385-e053-2995a90ac936	2024-12-20	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE HCL	Derma Care Research Labs, LLC	ff227154-cf3b-9796-e053-6294a90a5535	2024-12-20	Warnings	Exact identifier application number: M017
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE HCL 4%	Meijer	f31b11ed-2ff9-5cfc-e053-2a95a90af2ca	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier application number: M017
Mirakel Pain and Itch Relief	BENZOCAINE 20%, RESORCINOL 3%	Sanvio, Inc.	ed34d728-0275-e209-e053-2995a90a93ff	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE 4%	Meijer	bed67c31-c479-6f9b-e053-2a95a90a5516	2024-12-20	Warnings	Exact identifier application number: M017
Blue-Emu Ultra with Hemp Seed	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9	2024-12-20	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e5f3edc2-1b79-533a-e053-2a95a90ae9b6	2024-12-19	Warnings	Exact identifier application number: M017
Leader	LIDOCAINE HCL	Cardinal Health	cea6bd2d-a265-1209-e053-2995a90ab0a5	2024-12-19	Warnings	Exact identifier application number: M017
Rugby Anti-Itch	CAMPHOR, MENTHOL	RUGBY LABORATORIES	99d8ad9e-46ec-15fc-e053-2995a90a0d17	2024-12-19	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2672826	menthol 7.66 % Topical Ointment	PSN	b36eb017-ed8d-476e-994b-22b275e00543	1
2672826	menthol 0.0766 MG/MG Topical Ointment	SCD	b36eb017-ed8d-476e-994b-22b275e00543	1
2672826	menthol 7.66 % Topical Ointment	SY	b36eb017-ed8d-476e-994b-22b275e00543	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83570-443-02	83570044302	60 mL in 1 JAR (83570-443-02)	60 ml	2024-01-08	No	No	Current
83570-443-03	83570044303	103.5 mL in 1 JAR (83570-443-03)	103.5 ml	2024-01-08	No	No	Current
83570-443-07	83570044307	207 mL in 1 JAR (83570-443-07)	207 ml	2024-01-08	No	No	Current
83570-443-14	83570044314	414 mL in 1 JAR (83570-443-14)	414 ml	2024-01-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OWELL NATURALS Deep Penetrating Pain Relief Ointment	OWELL NATURALS BRAND, LLC	2024-01-02	HUMAN OTC DRUG LABEL	1