FDA.reportPublic FDA data

FOOT PAIN RELIEF ROLL-ON

Product NDC
84165-017
11-digit product format
841650017
Labeler code
84165
Product ID
84165-017_43edcea0-ab05-f368-e063-6294a90a817a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Zhupuyou E-commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-19
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 g/100mL; g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
FOOT PAIN RELIEF ROLL-ON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100mL
MENTHOL1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252967Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43edcea0-ab04-f368-e063-6294a90a817aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84165-017-01FOOT PAIN RELIEF ROLL-ON1 in 1 BOXLIQUID11
84165-017-01FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-02FOOT PAIN RELIEF ROLL-ON2 in 1 BOXLIQUID21
84165-017-02FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-03FOOT PAIN RELIEF ROLL-ON3 in 1 BOXLIQUID31
84165-017-03FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-04FOOT PAIN RELIEF ROLL-ON4 in 1 BOXLIQUID41
84165-017-04FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-05FOOT PAIN RELIEF ROLL-ON5 in 1 BOXLIQUID51
84165-017-05FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-06FOOT PAIN RELIEF ROLL-ON6 in 1 BOXLIQUID61
84165-017-06FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-07FOOT PAIN RELIEF ROLL-ON7 in 1 BOXLIQUID71
84165-017-07FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-08FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-08FOOT PAIN RELIEF ROLL-ON8 in 1 BOXLIQUID81
84165-017-09FOOT PAIN RELIEF ROLL-ON9 in 1 BOXLIQUID91
84165-017-09FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731
84165-017-10FOOT PAIN RELIEF ROLL-ON10 in 1 BOXLIQUID101
84165-017-10FOOT PAIN RELIEF ROLL-ON73 mL in 1 BOTTLELIQUID731

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 150 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
application number: M017
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bbee66b9-39ff-4e7e-e053-2995a90a43be2023-10-25WarningsExact identifier
application number: M017
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
application number: M017
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.cddc9c4a-7c58-4225-921a-05d6afb491782023-10-24WarningsExact identifier
application number: M017
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
application number: M017
Numfast Tetracaine GreenTETRACAINEUnit Dose, Ltd.77d9e6ea-1cd3-4447-ba74-01cd7143e27c2023-10-19WarningsExact identifier
application number: M017
LiprotekPETROLATUM, LIDOCAINEUnit Dose, Ltd.051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa52023-10-19WarningsExact identifier
application number: M017
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
application number: M017
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252967lidocaine 4 % / menthol 1 % Topical SolutionPSN43edcea0-ab04-f368-e063-6294a90a817a1
252967lidocaine 40 MG/ML / menthol 10 MG/ML Topical SolutionSCD43edcea0-ab04-f368-e063-6294a90a817a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-017-01841650017011 BOTTLE in 1 BOX (84165-017-01) / 73 mL in 1 BOTTLE1 bottle2025-11-19NoNoCurrent
84165-017-02841650017022 BOTTLE in 1 BOX (84165-017-02) / 73 mL in 1 BOTTLE2 bottle2025-11-19NoNoCurrent
84165-017-03841650017033 BOTTLE in 1 BOX (84165-017-03) / 73 mL in 1 BOTTLE3 bottle2025-11-19NoNoCurrent
84165-017-04841650017044 BOTTLE in 1 BOX (84165-017-04) / 73 mL in 1 BOTTLE4 bottle2025-11-19NoNoCurrent
84165-017-05841650017055 BOTTLE in 1 BOX (84165-017-05) / 73 mL in 1 BOTTLE5 bottle2025-11-19NoNoCurrent
84165-017-06841650017066 BOTTLE in 1 BOX (84165-017-06) / 73 mL in 1 BOTTLE6 bottle2025-11-19NoNoCurrent
84165-017-07841650017077 BOTTLE in 1 BOX (84165-017-07) / 73 mL in 1 BOTTLE7 bottle2025-11-19NoNoCurrent
84165-017-08841650017088 BOTTLE in 1 BOX (84165-017-08) / 73 mL in 1 BOTTLE8 bottle2025-11-19NoNoCurrent
84165-017-09841650017099 BOTTLE in 1 BOX (84165-017-09) / 73 mL in 1 BOTTLE9 bottle2025-11-19NoNoCurrent
84165-017-108416500171010 BOTTLE in 1 BOX (84165-017-10) / 73 mL in 1 BOTTLE10 bottle2025-11-19NoNoCurrent