Home NDC 61010-5000-0 Lidocaine Hydrochloride
Product NDC 61010-5000
Requested package NDC 61010-5000-0
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 68 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aulief Topical Pain Reliever MENTHOL AND CAMOHOR China-Gel, LLC 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC 254abae9-ef1b-5a90-e054-00144ff88e88 2025-11-04 Warnings Exact identifier application number: M017 Pain Relief Gel-Tube MENTHOL Bullet point LLC 42c93789-9758-54b7-e063-6394a90ac398 2025-11-04 Warnings Exact identifier application number: M017 Tattoo care TATTOO CARE CREAM Perfso (HK) Co., Limited 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 2025-11-04 Warnings Exact identifier application number: M017 CORE RELIEF CAMPHOR, MENTHOL Copper Joint, LLC 42d17270-f58d-9d69-e063-6294a90a4078 2025-11-04 Warnings Exact identifier application number: M017 Lidocaine and Menthol LIDOCAINE AND MENTHOL Marcella Health d25f25ee-79f8-49e7-9715-0aae305b73e5 2025-11-03 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS NO TOUCH SPRAY Premier Brands of America Inc. 36481d67-2346-470b-e063-6294a90aae99 2025-11-03 Warnings Exact identifier application number: M017 Lidocaine Numbing Cream LIDOCAINE 5% YYBA Corp 1319ee69-8b3f-5815-e063-6294a90a5ad5 2025-11-03 Warnings Exact identifier application number: M017 Goodsense Extra Strength Cold and Hot Medicated MENTHOL Geiss, Destin and Dunn, Inc. 7585d111-775f-4fb6-a485-28cd99d88852 2025-10-31 Warnings Exact identifier application number: M017 Topcare Cold and Hot Medicated MENTHOL Topco Associates LLC 8739aedd-165c-5ae0-e053-2a91aa0afcd0 2025-10-31 Warnings Exact identifier application number: M017 CVS Medicated Heat 1 ct CAPSAICIN CVS Pharmacy, Inc. d41dce5b-e698-4930-8869-040b2a973f25 2025-10-31 Warnings Exact identifier application number: M017 Coralite Medicated Heat CAPSAICIN United Exchange Corp. a0b89c7e-80bc-43c4-840c-5fd567f60b21 2025-10-31 Warnings Exact identifier application number: M017 Dragon with Arnical Pain Relief MENTHOL Genomma Lab USA Inc. b4cbb7b6-cb71-9721-e053-2995a90a2b2c 2025-10-31 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY SOLID Ointment. GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. Guangdong Quadrant Ecological Technology Co., Ltd. 425b1b9d-c33a-05e9-e063-6394a90a97a6 2025-10-30 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY Spray. GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. Guangdong Quadrant Ecological Technology Co., Ltd. 425b8259-af38-8d68-e063-6394a90a1120 2025-10-30 Warnings Exact identifier application number: M017 Family Care Muscle and Joint MENTHOL United Exchange Corp. 959af9f4-7188-91a1-e053-2995a90a4665 2025-10-30 Warnings Exact identifier application number: M017 CVS Maximum Strength Boil Relief BENZOCAINE CVS Pharmacy, Inc. 0761b866-af34-42bd-adc9-3d229170d01c 2025-10-30 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44ca52d-fec8-0e8c-e053-2995a90a2e60 2025-10-30 Warnings Exact identifier application number: M017 CVS CAPSAICIN CAPSAICIN CVS PHARMACY 9b551fe3-3842-482a-9042-63de5ad39884 2025-10-30 Warnings Exact identifier application number: M017 TopCare Health Pain Relief MENTHOL, CAMPHOR, AND METHYL SALICYLATE Topco Associates LLC dac364ef-6dcd-3fc6-e053-2a95a90a9bb2 2025-10-30 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