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 141 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Regular Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	CVS	87473ace-d834-e43f-e053-2a95a90a819c	2023-12-11	Warnings	Exact identifier application number: M017
Katinko External Analgesic Oil	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	5881fc35-3293-4f0b-801a-afcd6feb9496	2023-12-08	Warnings	Exact identifier application number: M017
Katinko Pain And Itch Relieving	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	fe907fa4-4a01-4974-b71f-9cd980b4eaa2	2023-12-08	Warnings, Adverse reactions	Exact identifier application number: M017
Cycle	MENTHOL	La Mend, Inc.	cfc0bcde-ef91-1e6c-e053-2a95a90ab79e	2023-12-07	Warnings	Exact identifier application number: M017
Hemorrhoidal Pain Relief Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	WALGREENS	03bbe146-f185-bcfa-e063-6394a90a85bf	2023-12-04	Warnings	Exact identifier application number: M017
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Exact identifier application number: M017
TACT	DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL	Sato Pharmaceutical Inc., Ltd.	b6e2ee24-69de-4dfd-9081-b9537b7a7bad	2023-12-04	Warnings	Exact identifier application number: M017
Overnight Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	2cbd0966-4cf9-4271-bd53-6672b1ed2a99	2023-12-04	Warnings	Exact identifier application number: M017
Prolayed Lidocaine Male Genital Desensitizer	LIDOCAINE	ViaDerma Distribution, Inc.	9c5ad0d0-ca7a-4321-9334-f06f3f6be18f	2023-12-02	Warnings	Exact identifier application number: M017
Liberdol Topical Analgesic	METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)	ViaDerma Distribution, Inc	ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8	2023-12-01	Warnings	Exact identifier application number: M017
Prolayed	LIDOCAINE	MATRIX MIXOLOGY, INC	ae317876-adb1-6d13-e053-2995a90a74af	2023-12-01	Warnings	Exact identifier application number: M017
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	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