Home NDC 84165-003 Lidocaine Pain Relief Gel Roll-On
Product NDC 84165-003
11-digit product format 841650003
Labeler code 84165
Product ID 84165-003_3c0de968-7f46-7db6-e063-6394a90add34
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE
Dosage form GEL
Route TOPICAL
Labeler Guangzhou Zhupuyou E-commerce Co., Ltd
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-28
Substance MENTHOL; LIDOCAINE
Active strength .01; .04 g/mL; g/mL
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 Lidocaine Pain Relief Gel Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .01 g/mL LIDOCAINE .04 g/mL
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 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1804176 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84165-003-01 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-01 Lidocaine Pain Relief Gel Roll-On 1 in 1 BOX GEL 1 3 84165-003-02 Lidocaine Pain Relief Gel Roll-On 2 in 1 BOX GEL 2 3 84165-003-02 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-03 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-03 Lidocaine Pain Relief Gel Roll-On 3 in 1 BOX GEL 3 3 84165-003-04 Lidocaine Pain Relief Gel Roll-On 4 in 1 BOX GEL 4 3 84165-003-04 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-05 Lidocaine Pain Relief Gel Roll-On 5 in 1 BOX GEL 5 3 84165-003-05 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-06 Lidocaine Pain Relief Gel Roll-On 6 in 1 BOX GEL 6 3 84165-003-06 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-07 Lidocaine Pain Relief Gel Roll-On 7 in 1 BOX GEL 7 3 84165-003-07 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-08 Lidocaine Pain Relief Gel Roll-On 8 in 1 BOX GEL 8 3 84165-003-08 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-09 Lidocaine Pain Relief Gel Roll-On 9 in 1 BOX GEL 9 3 84165-003-09 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3 84165-003-10 Lidocaine Pain Relief Gel Roll-On 10 in 1 BOX GEL 10 3 84165-003-10 Lidocaine Pain Relief Gel Roll-On 73 mL in 1 BOTTLE GEL 73 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84165-003 LIDOCAINE PAIN RELIEF GEL ROLL-ON (LIDOCAINE) GEL [GUANGZHOU ZHUPUYOU E-COMMERCE CO., LTD] 2 Current NDC, 20 package rows 20250418_31639407-0f11-bde2-e063-6294a90af694.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 59 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc 7d4e21d1-2914-4690-9084-a52abeab0958 2025-12-02 Warnings Exact identifier application number: M017 Rugby Capsaicin Cream CAPSAICIN Rugby Laboratories 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9 2025-12-02 Warnings Exact identifier application number: M017 Leader Capsaicin Pain Relief Cream CAPSAICIN Cardinal Health 110 dba LEADER a5620709-0fed-4979-e053-2a95a90ac654 2025-12-02 Warnings Exact identifier application number: M017 Hydrocortisone Acetate Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE Sun Pharmaceutical Industries, Inc. 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 2025-12-02 Warnings Exact identifier application number: M017 POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Exact identifier application number: M017 Thermacare Max Strength Lidocaine THERMACARE MAX STRENGTH LIDOCAINE Clarion Brands LLC 44fed887-d1e0-d205-e063-6294a90ac416 2025-12-02 Warnings Exact identifier application number: M017 SUNSET COOLING PAIN RELIEF ROLL-ON MENTHOL SUNSET NOVELTIES, INC 45037bc1-aa03-11ae-e063-6294a90a6c96 2025-12-02 Warnings Exact identifier application number: M017 SUNSET HEATING PAIN RELIEF ROLL-ON CAMPHOR SUNSET NOVELTIES, INC 45048936-f3c9-25f7-e063-6394a90ac4a9 2025-12-02 Warnings Exact identifier application number: M017 CAREALL Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM New World Imports, Inc 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 2025-12-01 Warnings Exact identifier application number: M017 CareALL Arthritis and Muscle CAPSAICIN New World Imports, Inc 4867eac4-00ea-434e-b289-1c1ef0342c23 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc cba7c084-379f-4a16-aeba-b11ca6e20d8a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc d066002d-8ceb-4d16-9744-d5ca25d2ad5a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 013beea4-b2c2-4e84-b4cb-3125ac48e8c0 2025-12-01 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN A2A Integrated Pharmaceuticals, LLC 147f3594-7362-7a78-e063-6294a90a3e42 2025-11-30 Warnings Exact identifier application number: M017 Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Exact identifier application number: M017 Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Exact identifier application number: M017 Itch Relief ITCH RELIEF GEL Neilmed Pharmaceuticals Inc. 44811828-c32e-17fc-e063-6294a90add48 2025-11-26 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON Clarion Brands LLC 4482d34d-eaca-5522-e063-6394a90a6afb 2025-11-26 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84165-003-01 84165000301 1 BOTTLE in 1 BOX (84165-003-01) / 73 mL in 1 BOTTLE 1 bottle 2025-03-28 No No Current 84165-003-02 84165000302 2 BOTTLE in 1 BOX (84165-003-02) / 73 mL in 1 BOTTLE 2 bottle 2025-03-28 No No Current 84165-003-03 84165000303 3 BOTTLE in 1 BOX (84165-003-03) / 73 mL in 1 BOTTLE 3 bottle 2025-03-28 No No Current 84165-003-04 84165000304 4 BOTTLE in 1 BOX (84165-003-04) / 73 mL in 1 BOTTLE 4 bottle 2025-03-28 No No Current 84165-003-05 84165000305 5 BOTTLE in 1 BOX (84165-003-05) / 73 mL in 1 BOTTLE 5 bottle 2025-03-28 No No Current 84165-003-06 84165000306 6 BOTTLE in 1 BOX (84165-003-06) / 73 mL in 1 BOTTLE 6 bottle 2025-03-28 No No Current 84165-003-07 84165000307 7 BOTTLE in 1 BOX (84165-003-07) / 73 mL in 1 BOTTLE 7 bottle 2025-03-28 No No Current 84165-003-08 84165000308 8 BOTTLE in 1 BOX (84165-003-08) / 73 mL in 1 BOTTLE 8 bottle 2025-03-28 No No Current 84165-003-09 84165000309 9 BOTTLE in 1 BOX (84165-003-09) / 73 mL in 1 BOTTLE 9 bottle 2025-03-28 No No Current 84165-003-10 84165000310 10 BOTTLE in 1 BOX (84165-003-10) / 73 mL in 1 BOTTLE 10 bottle 2025-03-28 No No Current