Menthozen Hydrogel

Product NDC: 71205-334
11-digit product format: 712050334
Labeler code: 71205
Product ID: 71205-334_1cdc9d1f-d8eb-40e4-99e6-286c7dbfb986
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAPSAICIN
Dosage form: PATCH
Route: TOPICAL
Labeler: Proficient Rx LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-01
Substance: MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength: 40; .3 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Menthozen Hydrogel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/g
CAPSAICIN	.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
S07O44R1ZM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2178283	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
85a7809e-c43f-4138-a85b-44e1b586def5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-334-05	Menthozen Hydrogel	5 in 1 POUCH	PATCH	5	6
71205-334-05	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-15	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-15	Menthozen Hydrogel	15 in 1 POUCH	PATCH	15	6
71205-334-30	Menthozen Hydrogel	1 g in 1 PATCH	PATCH	1	6
71205-334-30	Menthozen Hydrogel	30 in 1 POUCH	PATCH	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-334-05	EA - Each	71205-334	8ebe78c4-2a9d-4463-8852-5899b2e17c35	1	2021-02-05
71205-334-15	EA - Each	71205-334	87828063-afb9-4749-9f52-6c85aaf0ff01	1	2019-11-12
71205-334-30	EA - Each	71205-334	18a3e94d-b288-47ef-bfdf-b0ffb7facccc	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-334	MENTHOZEN HYDROGEL (MENTHOL, CAPSAICIN) PATCH [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 6 package rows	20231207_85a7809e-c43f-4138-a85b-44e1b586def5.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 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Anti-itch	HYDROCORTISONE	Rite Aid	0c540422-1579-9217-e063-6294a90ad06a	2023-12-12	Warnings	Exact identifier application number: M017
Anti-itch Paraben Free	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c5419c5-0929-7ca6-e063-6294a90ac0a7	2023-12-12	Warnings	Exact identifier application number: M017
Rite Aid Hydrocortisone	HYDROCORTISONE 1%	Rite Aid	0c580f96-7fe9-19df-e063-6394a90a5a22	2023-12-12	Warnings	Exact identifier application number: M017
Anti itch	HYDROCORTISONE	Weeks & Leo Co., Inc.	0c58b750-d3a6-5ed1-e063-6294a90a4321	2023-12-12	Warnings	Exact identifier application number: M017
Greencaine Blast	LIDOCAINE	ALMA Laboratories, Inc.	031e0065-4c8a-43d8-bc69-3efa3c6c0ae3	2023-12-12	Warnings	Exact identifier application number: M017
Ageless Pain Relief	METHYL SALICYLATE, MENTHOL	Isagenix International, LLC	3c7e493b-923d-44b1-9076-46c7894308d4	2023-12-12	Warnings, Adverse reactions	Exact identifier application number: M017
CVS Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	CVS	857af609-9dd7-a07a-e053-2991aa0ab6ba	2023-12-11	Warnings	Exact identifier application number: M017
Rite Aid Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Rite Aid	0c4170dd-e1fa-d549-e063-6394a90a5c23	2023-12-11	Warnings	Exact identifier application number: M017
Westlake Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Westlake HB Pharma LLC	0c416ba6-b01f-0609-e063-6294a90ae2a1	2023-12-11	Warnings	Exact identifier application number: M017
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2178283	capsaicin 0.03 % / menthol 4 % Medicated Patch	PSN	85a7809e-c43f-4138-a85b-44e1b586def5	6
2178283	capsaicin 0.0003 MG/MG / menthol 0.04 MG/MG Medicated Patch	SCD	85a7809e-c43f-4138-a85b-44e1b586def5	6
2178283	capsaicin 0.03 % / menthol 4 % Medicated Patch	SY	85a7809e-c43f-4138-a85b-44e1b586def5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-334-05	71205033405	5 PATCH in 1 POUCH (71205-334-05) / 1 g in 1 PATCH	5 patch	2020-11-20	0000-00-00	No	No	Current
71205-334-15	71205033415	15 PATCH in 1 POUCH (71205-334-15) / 1 g in 1 PATCH	15 patch	2019-09-01	0000-00-00	No	No	Current
71205-334-30	71205033430	30 PATCH in 1 POUCH (71205-334-30) / 1 g in 1 PATCH	30 patch	2019-09-01	0000-00-00	No	No	Current