Home NDC 0395-9130 Lidocaine Pain Relief Roll-On
Product NDC 0395-9130
11-digit product format 003959130
Labeler code 0395
Product ID 0395-9130_0c9380d5-c285-0902-e063-6394a90ac157
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form LIQUID
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-05
Substance LIDOCAINE HYDROCHLORIDE
Active strength 4 g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII 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 0395-9130-97 Lidocaine Pain Relief Roll-On 1 in 1 CARTON LIQUID 1 4 0395-9130-97 Lidocaine Pain Relief Roll-On 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-9130 LIDOCAINE PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [HUMCO HOLDING GROUP, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231216_a8be9e46-1616-40a9-e053-2a95a90ac3bc.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 44 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine HCI LIDOCAINE HCI Trifluent Pharma, LLC 47f7f06b-720e-eeec-e063-6294a90ae823 2026-01-09 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Bellus Medical, LLC 60cb89f6-e326-0773-e053-2a91aa0a33dd 2026-01-09 Warnings Exact identifier application number: M017 Tetracaine TETRACAINE Bellus Medical, LLC 60cabb5f-606b-7a74-e053-2a91aa0ac024 2026-01-09 Warnings Exact identifier application number: M017 Benzocaine BENZOCAINE Bellus Medical, LLC 60cafbaf-8ec6-46a5-e053-2a91aa0af11f 2026-01-09 Warnings Exact identifier application number: M017 PRAX PRAMOXINE HYDROCHLORIDE AvPAK dc646399-91ba-5cc1-e053-2a95a90a4f9c 2026-01-09 Warnings Exact identifier application number: M017 2.5% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC c842544a-6aea-42af-a77e-7b202371b387 2026-01-09 Warnings Exact identifier application number: M017 4% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC 7fb95135-4151-4ef4-bb6d-75251cafff6c 2026-01-09 Warnings Exact identifier application number: M017 Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Meijer Distribution, Inc 781f89c0-94ab-48de-9e0b-decb37bcde46 2026-01-09 Warnings Exact identifier application number: M017 LIDOCAINE PAIN RELIEVING Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2159fb73-cf6c-184a-e063-6394a90a1d14 2026-01-08 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 22d9ce20-1cb6-c5bd-e063-6394a90a9eca 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INT'L THERMO ANALGETICS ROLL-ON 76ef713b-e23d-7b98-e053-2991aa0aad51 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0ca84-2800-d222-e053-2995a90ad8f3 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5b0db6-8f0a-4f8e-e053-2995a90a22b7 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin Topical Analgesic CAPSAICIN AvPAK ef597423-cd01-7324-e053-2a95a90aa1ba 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN AvPAK ef5a3846-1d2f-7023-e053-2a95a90ad716 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5bb0fa-afc2-62d7-e053-2a95a90a37f4 2026-01-08 Warnings Exact identifier application number: M017 K2 Cold Therapy MENTHOL The Podiatree Co 60dce1ad-125e-396d-e053-2a91aa0a670f 2026-01-08 Warnings Exact identifier application number: M017 Burn Relief Aloe LIDOCAINE HCL Acutens 48c435fe-2670-4b80-bf01-923dc9354422 2026-01-08 Warnings Exact identifier application number: M017 Relieve A Pain LIDOCAINE Relieve A Pain LLC cafaa830-d894-4590-8928-d579cc791d79 2026-01-08 Warnings Exact identifier application number: M017 DZUL ARTHRITIS PAIN RELIEF MENTHOL Caball Sales, Inc. 159c301c-d462-bb2c-e063-6394a90a9e5a 2026-01-08 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0395-9130-97 00395913097 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0395-9130-97) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2019-06-05 0000-00-00 No No Current