FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL, UNSPECIFIED FORM40 mg/g
CAPSAICIN.3 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2178283Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85a7809e-c43f-4138-a85b-44e1b586def5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-334-05Menthozen Hydrogel5 in 1 POUCHPATCH56
71205-334-05Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-15Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-15Menthozen Hydrogel15 in 1 POUCHPATCH156
71205-334-30Menthozen Hydrogel1 g in 1 PATCHPATCH16
71205-334-30Menthozen Hydrogel30 in 1 POUCHPATCH306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-334-05EA - Each71205-3348ebe78c4-2a9d-4463-8852-5899b2e17c3512021-02-05
71205-334-15EA - Each71205-33487828063-afb9-4749-9f52-6c85aaf0ff0112019-11-12
71205-334-30EA - Each71205-33418a3e94d-b288-47ef-bfdf-b0ffb7facccc12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-334MENTHOZEN HYDROGEL (MENTHOL, CAPSAICIN) PATCH [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20231207_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 148 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprises391af69f-74aa-48cf-bc96-75e5c4e0e4452023-11-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178283capsaicin 0.03 % / menthol 4 % Medicated PatchPSN85a7809e-c43f-4138-a85b-44e1b586def56
2178283capsaicin 0.0003 MG/MG / menthol 0.04 MG/MG Medicated PatchSCD85a7809e-c43f-4138-a85b-44e1b586def56
2178283capsaicin 0.03 % / menthol 4 % Medicated PatchSY85a7809e-c43f-4138-a85b-44e1b586def56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-334-05712050334055 PATCH in 1 POUCH (71205-334-05) / 1 g in 1 PATCH5 patch2020-11-200000-00-00NoNoCurrent
71205-334-157120503341515 PATCH in 1 POUCH (71205-334-15) / 1 g in 1 PATCH15 patch2019-09-010000-00-00NoNoCurrent
71205-334-307120503343030 PATCH in 1 POUCH (71205-334-30) / 1 g in 1 PATCH30 patch2019-09-010000-00-00NoNoCurrent