FDA.reportPublic FDA data

PLANTAR FASCIITIS Relief Gel Roll-On

Product NDC
84165-012
11-digit product format
841650012
Labeler code
84165
Product ID
84165-012_37570149-dae2-a4f2-e063-6294a90a3245
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Zhupuyou E-commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-12
Substance
MENTHOL
Active strength
4 g/100mL
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
PLANTAR FASCIITIS Relief Gel Roll-On
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

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
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37570149-dae1-a4f2-e063-6294a90a3245Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84165-012-01PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-01PLANTAR FASCIITIS Relief Gel Roll-On1 in 1 BOXGEL11
84165-012-02PLANTAR FASCIITIS Relief Gel Roll-On2 in 1 BOXGEL21
84165-012-02PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-03PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-03PLANTAR FASCIITIS Relief Gel Roll-On3 in 1 BOXGEL31
84165-012-04PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-04PLANTAR FASCIITIS Relief Gel Roll-On4 in 1 BOXGEL41
84165-012-05PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-05PLANTAR FASCIITIS Relief Gel Roll-On5 in 1 BOXGEL51
84165-012-06PLANTAR FASCIITIS Relief Gel Roll-On6 in 1 BOXGEL61
84165-012-06PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-07PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-07PLANTAR FASCIITIS Relief Gel Roll-On7 in 1 BOXGEL71
84165-012-08PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-08PLANTAR FASCIITIS Relief Gel Roll-On8 in 1 BOXGEL81
84165-012-09PLANTAR FASCIITIS Relief Gel Roll-On9 in 1 BOXGEL91
84165-012-09PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-10PLANTAR FASCIITIS Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-012-10PLANTAR FASCIITIS Relief Gel Roll-On10 in 1 BOXGEL101

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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact identifier
application number: M017
PURE EASE Neur Cream Instant Deep Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.e46a4636-6405-440a-a05a-862c354bab542023-11-13WarningsExact identifier
application number: M017
Cryomax CoolingMENTHOLLIFE WEAR TECHNOLOGIES0a0ae5ba-9fac-45f6-e063-6294a90ad5552023-11-13WarningsExact identifier
application number: M017
LBri Super Aloe Stop The PainMETHYL SALICYLATE, MENTHOL, CAPSAICINL'Bris, Pure 'N Natural8fb2010c-c34b-4552-858d-a0188ad313ad2023-11-11WarningsExact identifier
application number: M017
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
application number: M017
Human Science Muscle Pain ReliefMETHYL SALICYLATE, MENTHOLHuman Science, LLC4bccc017-264b-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
application number: M017
GOLD ICE Pain ReliefMENTHOLEden's Answers, Inc.a1356c39-42b9-4bd8-a873-bcd40717058b2023-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN37570149-dae1-a4f2-e063-6294a90a32451
415974menthol 0.04 MG/MG Topical GelSCD37570149-dae1-a4f2-e063-6294a90a32451
415974menthol 4 % Topical GelSY37570149-dae1-a4f2-e063-6294a90a32451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-012-01841650012011 BOTTLE in 1 BOX (84165-012-01) / 74 mL in 1 BOTTLE1 bottle2025-06-12NoNoCurrent
84165-012-02841650012022 BOTTLE in 1 BOX (84165-012-02) / 74 mL in 1 BOTTLE2 bottle2025-06-12NoNoCurrent
84165-012-03841650012033 BOTTLE in 1 BOX (84165-012-03) / 74 mL in 1 BOTTLE3 bottle2025-06-12NoNoCurrent
84165-012-04841650012044 BOTTLE in 1 BOX (84165-012-04) / 74 mL in 1 BOTTLE4 bottle2025-06-12NoNoCurrent
84165-012-05841650012055 BOTTLE in 1 BOX (84165-012-05) / 74 mL in 1 BOTTLE5 bottle2025-06-12NoNoCurrent
84165-012-06841650012066 BOTTLE in 1 BOX (84165-012-06) / 74 mL in 1 BOTTLE6 bottle2025-06-12NoNoCurrent
84165-012-07841650012077 BOTTLE in 1 BOX (84165-012-07) / 74 mL in 1 BOTTLE7 bottle2025-06-12NoNoCurrent
84165-012-08841650012088 BOTTLE in 1 BOX (84165-012-08) / 74 mL in 1 BOTTLE8 bottle2025-06-12NoNoCurrent
84165-012-09841650012099 BOTTLE in 1 BOX (84165-012-09) / 74 mL in 1 BOTTLE9 bottle2025-06-12NoNoCurrent
84165-012-108416500121010 BOTTLE in 1 BOX (84165-012-10) / 74 mL in 1 BOTTLE10 bottle2025-06-12NoNoCurrent