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 60 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d129641-eaea-c3ee-e063-6394a90aa58f 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d1059cc-1b0b-4e7b-e063-6294a90a56ea 2025-11-24 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL AND CAMPHOR GURUNANDA, LLC 3ca78342-cc6d-5f6b-e063-6294a90a3f1c 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d118256-90ee-28ef-e063-6394a90a21e8 2025-11-24 Warnings Exact identifier application number: M017 health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 3 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4429fea8-46f8-8f7f-e063-6394a90a34b4 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 2 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442a926b-d7c1-4e35-e063-6394a90ad948 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442aae32-4ac6-5dd6-e063-6294a90aad02 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1-3 Step 21MG NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442ae0fa-a1ed-7901-e063-6294a90ab717 2025-11-22 Warnings Exact identifier application number: M017 IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 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