Home NDC 61010-5000 Lidocaine Hydrochloride
Product NDC 61010-5000
11-digit product format 610105000
Labeler code 61010
Product ID 61010-5000_10d33035-4a33-6917-e063-6294a90ac896
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-09-19
Substance LIDOCAINE HYDROCHLORIDE
Active strength 20 mg/g
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 Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 20 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5000-0 2024-02-07 61010-5000, Burn Gel 61010-5000-1 2024-02-07 61010-5000, Burn Gel 61010-5000-3 2024-02-07 61010-5000, Burn Gel 61010-5000-4 2024-02-07 61010-5000, Burn Gel 61010-5000-5 2024-02-07 61010-5000, Burn Gel 61010-5000-6 2024-02-07 61010-5000, Burn Gel 61010-5000-0 2024-01-30 61010-5000, Burn Gel 61010-5000-1 2024-01-30 61010-5000, Burn Gel 61010-5000-3 2024-01-30 61010-5000, Burn Gel 61010-5000-4 2024-01-30 61010-5000, Burn Gel 61010-5000-5 2024-01-30 61010-5000, Burn Gel 61010-5000-6 2024-01-30 61010-5000, Burn Gel
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5000-0 Lidocaine Hydrochloride 3.3 g in 1 PACKET GEL 3.3 5 61010-5000-1 Lidocaine Hydrochloride 121.2 g in 1 BOTTLE GEL 121.2 5 61010-5000-3 Lidocaine Hydrochloride 0.9 g in 1 POUCH GEL 0.9 5 61010-5000-4 Lidocaine Hydrochloride 144 in 1 CARTON GEL 144 5 61010-5000-4 Lidocaine Hydrochloride 0.9 g in 1 POUCH GEL 0.9 5 61010-5000-5 Lidocaine Hydrochloride 0.9 g in 1 POUCH GEL 0.9 5 61010-5000-5 Lidocaine Hydrochloride 25 in 1 CARTON GEL 25 5 61010-5000-6 Lidocaine Hydrochloride 0.9 g in 1 PACKET GEL 0.9 5 61010-5000-6 Lidocaine Hydrochloride 10 in 1 BOX GEL 10 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Lidocaine Hydrochloride ACTIVE INGREDIENT V13007Z41A LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 Lidocaine ACTIVE MOIETY 98PI200987 LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 .alpha.-tocopherol acetate INACTIVE INGREDIENT 9E8X80D2L0 LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 menthol INACTIVE INGREDIENT L7T10EIP3A LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 trolamine INACTIVE INGREDIENT 9O3K93S3TK LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5000 LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.] 5 Current NDC, Legacy NDC, 9 package rows 20240208_1c5eb3b3-79b3-472a-ae36-ec6a7dc72925.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 131 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Brand Medicated Roll On MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1bc2f688-d0c4-690e-e063-6294a90abc38 2024-06-25 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 1b9fdac0-9fb0-e669-e063-6394a90aece9 2024-06-24 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Asclemed USA, Inc. 97d506bd-3215-4e2e-9914-af1c174dd4ab 2024-06-20 Warnings Exact identifier application number: M017 ABREVA Rapid Pain Relief GLYCERIN, LIDOCAINE Haleon US Holdings LLC 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d 2024-06-20 Warnings Exact identifier application number: M017 Frankie Avalons ZERO PAIN Roll-On Pain Reliever CAPSAICIN WHY ENTERPRISES LLC e32acb5f-5bc3-4228-b037-6315d080f556 2024-06-17 Warnings Exact identifier application number: M017 PUREGEN LABS Pain Relief 4 Lidocaine LIDOCAINE Advanced Rx LLC 9dff40d8-8d7e-4629-bea5-987f5e68477d 2024-06-11 Warnings Exact identifier application number: M017 SMOOTH GATOR Head-Ezz Analgesic MENTHOL Smooth Gator LLC 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd 2024-06-10 Warnings Exact identifier application number: M017 FIRST AID BURN LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE Epic Medical Supply Corp bd1b1873-e900-45eb-96a0-28f782b5a7cd 2024-06-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Chain Drug Marketing Association Inc. 1c834ba0-86b6-8e61-e063-6394a90a192d 2024-06-04 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 19fe7c3b-58e2-6c16-e063-6394a90a612a 2024-06-03 Warnings Exact identifier application number: M017 THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE SCALP TECH INC 184be4cc-b0b9-7882-e063-6394a90a8e7e 2024-05-25 Warnings Exact identifier application number: M017 Methyl Salicylate 25 Percent METHYL SALICYLATE Alexso, Inc d8b8b0ba-69e9-4965-bf9b-6db21db69b34 2024-05-23 Warnings Exact identifier application number: M017 Meijer Medicated Chest Rub CAMPHOR, MENTHOL, EUCALYPTUS OIL Meijer Distribution 07ecc6a7-bbe3-35cf-e063-6394a90a2180 2024-05-22 Warnings Exact identifier application number: M017 TheraCare Hydrocortisone Cream HYDROCORTISONE Veridian Healthcare 01cb7b47-2c3c-707d-e063-6294a90a5d97 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare c808aa05-9d49-cc9f-e053-2a95a90a50f3 2024-05-21 Warnings Exact identifier application number: M017 TheraCare 4% Lidocaine and 1% Menthol Cream MENTHOL AND LIDOCAINE Veridian Healthcare c80ba251-91a5-0858-e053-2995a90a9cff 2024-05-21 Warnings Exact identifier application number: M017 HealthWise Menthol Roll-On MENTHOL Veridian Healthcare 102d57a5-6449-f825-e063-6294a90a8844 2024-05-21 Warnings Exact identifier application number: M017 SAFLY Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. 3aca2568-d10f-4b14-861b-6c741c106829 2024-05-17 Warnings Exact identifier application number: M017 HealthWise Menthol 4% Roll-On MENTHOL Veridian Healthcare 1894ef00-ba05-0e02-e063-6394a90ab982 2024-05-16 Warnings Exact identifier application number: M017 Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 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 Marketing end Sample Exclude flag Status 61010-5000-0 61010500000 3.3 g in 1 PACKET (61010-5000-0) 3.3 g 2012-09-19 0000-00-00 No No Current 61010-5000-1 61010500001 121.2 g in 1 BOTTLE (61010-5000-1) 121.2 g 2012-09-19 0000-00-00 No No Current 61010-5000-3 61010500003 .9 g in 1 POUCH (61010-5000-3) 2012-09-19 0000-00-00 No No Current 61010-5000-4 61010500004 144 POUCH in 1 CARTON (61010-5000-4) / .9 g in 1 POUCH 144 pouch 2012-09-19 0000-00-00 No No Current 61010-5000-5 61010500005 25 POUCH in 1 CARTON (61010-5000-5) / .9 g in 1 POUCH 25 pouch 2012-09-19 0000-00-00 No No Current 61010-5000-6 61010500006 10 PACKET in 1 BOX (61010-5000-6) / .9 g in 1 PACKET 10 packet 2020-04-01 0000-00-00 No No Current