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 114 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Maximum Strength Pain Relief Patch LIDOCAINE Veridian Healthcare dfaf8a77-2276-4791-e053-2a95a90a3288 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017 Medicaine Sting and Bite BENZOCAINE James Alexander Corporation 753e6cbe-31e0-4017-93d0-8b4bf5972f37 2024-12-09 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. df239c4d-af6a-41ca-baed-d0788782ce9f 2024-12-08 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on LIDOCAINE SHENZHEN YUWEN E-COMMERCE CO., LTD. 8b30f623-6077-4f2e-8fa4-ce4a298953b5 2024-12-08 Warnings Exact identifier application number: M017 QC Medicated anti itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chain Drug Marketing Association b5e41e3a-81df-3a63-e053-2a95a90a5839 2024-12-08 Warnings Exact identifier application number: M017 QC Lidocaine Maximum Strength LIDOCAINE HCL Chain Drug Marketing Association b5e1b1ab-8a95-2d2d-e053-2995a90aea53 2024-12-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Alexso, Inc 433da27d-04fb-481a-bbb0-874bb72c806a 2024-12-06 Warnings Exact identifier application number: M017 POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Exact identifier application number: M017 Capsaicin 0.1 Percent CAPSAICIN Alexso, Inc 0090ca38-6433-45c4-9453-edf2788c14c6 2024-12-06 Warnings Exact identifier application number: M017 Signature Care Menthol MENTHOL 4% Safeway 27d3cb47-a6c7-5b7a-e063-6394a90a056f 2024-12-05 Warnings Exact identifier application number: M017 ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE BF ASCHER AND CO INC 03c16d33-8f59-0184-e054-00144ff8d46c 2024-12-05 Warnings Exact identifier application number: M017 PO First Aid Series BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. f1c349a8-216d-4233-922e-c95329a33d1e 2024-12-05 Warnings Exact identifier application number: M017 Post Treatment Balm HYDROCORTISONE Allure Labs Inc. faa803e6-453c-4d86-85dd-5a5dcdd72d02 2024-12-05 Warnings Exact identifier application number: M017 CBD Pain Relief Cream TROLAMINE SALICYLATE Allure Labs b6b3102a-4154-2da2-e053-2995a90ae99f 2024-12-05 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