FDA.reportPublic FDA data

HEEL PAIN Relief Gel Roll-On

Product NDC
84165-011
11-digit product format
841650011
Labeler code
84165
Product ID
84165-011_36bacb5f-c1b0-2e97-e063-6394a90afe5c
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
2025-06-04
Substance
MENTHOL
Active strength
.04 g/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
HEEL PAIN Relief Gel Roll-On
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.04 g/mL

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
36bacb5f-c1af-2e97-e063-6394a90afe5cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84165-011-01HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-01HEEL PAIN Relief Gel Roll-On1 in 1 BOXGEL11
84165-011-02HEEL PAIN Relief Gel Roll-On2 in 1 BOXGEL21
84165-011-02HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-03HEEL PAIN Relief Gel Roll-On3 in 1 BOXGEL31
84165-011-03HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-04HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-04HEEL PAIN Relief Gel Roll-On4 in 1 BOXGEL41
84165-011-05HEEL PAIN Relief Gel Roll-On5 in 1 BOXGEL51
84165-011-05HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-06HEEL PAIN Relief Gel Roll-On6 in 1 BOXGEL61
84165-011-06HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-07HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-07HEEL PAIN Relief Gel Roll-On7 in 1 BOXGEL71
84165-011-08HEEL PAIN Relief Gel Roll-On8 in 1 BOXGEL81
84165-011-08HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-09HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-09HEEL PAIN Relief Gel Roll-On9 in 1 BOXGEL91
84165-011-10HEEL PAIN Relief Gel Roll-On74 mL in 1 BOTTLEGEL741
84165-011-10HEEL PAIN 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 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN36bacb5f-c1af-2e97-e063-6394a90afe5c1
415974menthol 0.04 MG/MG Topical GelSCD36bacb5f-c1af-2e97-e063-6394a90afe5c1
415974menthol 4 % Topical GelSY36bacb5f-c1af-2e97-e063-6394a90afe5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-011-01841650011011 BOTTLE in 1 BOX (84165-011-01) / 74 mL in 1 BOTTLE1 bottle2025-06-04NoNoCurrent
84165-011-02841650011022 BOTTLE in 1 BOX (84165-011-02) / 74 mL in 1 BOTTLE2 bottle2025-06-04NoNoCurrent
84165-011-03841650011033 BOTTLE in 1 BOX (84165-011-03) / 74 mL in 1 BOTTLE3 bottle2025-06-04NoNoCurrent
84165-011-04841650011044 BOTTLE in 1 BOX (84165-011-04) / 74 mL in 1 BOTTLE4 bottle2025-06-04NoNoCurrent
84165-011-05841650011055 BOTTLE in 1 BOX (84165-011-05) / 74 mL in 1 BOTTLE5 bottle2025-06-04NoNoCurrent
84165-011-06841650011066 BOTTLE in 1 BOX (84165-011-06) / 74 mL in 1 BOTTLE6 bottle2025-06-04NoNoCurrent
84165-011-07841650011077 BOTTLE in 1 BOX (84165-011-07) / 74 mL in 1 BOTTLE7 bottle2025-06-04NoNoCurrent
84165-011-08841650011088 BOTTLE in 1 BOX (84165-011-08) / 74 mL in 1 BOTTLE8 bottle2025-06-04NoNoCurrent
84165-011-09841650011099 BOTTLE in 1 BOX (84165-011-09) / 74 mL in 1 BOTTLE9 bottle2025-06-04NoNoCurrent
84165-011-108416500111010 BOTTLE in 1 BOX (84165-011-10) / 74 mL in 1 BOTTLE10 bottle2025-06-04NoNoCurrent