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 77 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ink Scribd Numbing LIDOCAINE HCL Prodigy Media Inc 54173858-aff0-43b2-bc7b-c4ecab9bc3e5 2025-09-17 Warnings Exact identifier application number: M017 Inkorporated Numbing LIDOCAINE HCL Prodigy Media Inc 3017056c-f3c6-4300-8344-bf6e7d32e870 2025-09-17 Warnings Exact identifier application number: M017 TattooGirl Numbing LIDOCAINE HCL Prodigy Media Inc 6abe4540-f6c9-412a-83f3-682df7715057 2025-09-17 Warnings Exact identifier application number: M017 Dr Tatty Numbing LIDOCAINE HCL Prodigy Media Inc 5bb558c1-bf8f-4956-8732-e19720f62f31 2025-09-17 Warnings Exact identifier application number: M017 Burn Ease Cooling LIDOCAINE ProStat First Aid LLC ec201ca1-efa0-4797-aec3-115647c29abd 2025-09-17 Warnings Exact identifier application number: M017 MedFreeze Naturally Cool Pain Relief MENTHOL MEDKO LLC 240f2346-c585-4334-997c-45db6268d7c4 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK DUAL HOT AND COLD METHYL SALICYLATE, MENTHOL Natureteq Inc. ba5f4626-f077-4a28-8dcc-dacd50741ead 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK ICE MENTHOL, CAMPHOR Natureteq Inc. c1077744-7b9a-4536-8faf-e21994a43ea5 2025-09-15 Warnings Exact identifier application number: M017 Caring Mills Vaginal Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare cd379e74-2841-47e4-b95a-de1b341b397f 2025-09-15 Warnings Exact identifier application number: M017 Lidocaine-Pain-Relief-Patch LIDOCAINE-PAIN-RELIEF-PATCH Henan Enokon Medical Instrument Co., Ltd. 3ecfa867-50f6-d98a-e063-6394a90aefa0 2025-09-14 Warnings Exact identifier application number: M017 Meijer Hydrocortsione Cream HYDROCORTSIONE CREAM 1% Meijer Distribution Inc. 1cbddb7e-f2e3-0951-e063-6394a90a3d37 2025-09-12 Warnings Exact identifier application number: M017 JO Prolonger with Benzocaine BENZOCAINE CC Wellness LLC d955f612-1267-f1be-e053-2995a90a5345 2025-09-12 Warnings Exact identifier application number: M017 JO for Him Prolonger with Lidocaine LIDOCAINE CC Wellness LLC b12dc6a3-142d-3219-e053-2995a90aead0 2025-09-12 Warnings Exact identifier application number: M017 Walgreens Medicated Foot Powder MENTHOL Davion, Inc 58e1e7f7-6284-411f-9765-0e63eabca0f3 2025-09-12 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Amerisource Bergen 614f1e56-891f-4620-be10-0c075a1dbc3f 2025-09-11 Warnings Exact identifier application number: M017 Industrial Itch and Pain Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE R & R Lotion, Inc 236415fc-f923-4a82-b54a-ecaf666dd2e0 2025-09-11 Warnings Exact identifier application number: M017 Eco Lips Menthol Medicated Lip Balm MENTHOL Eco Lips, Inc. fc4c25d6-6109-dfd8-e053-6394a90a4e91 2025-09-10 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE 1% Encube Ethicals, Inc. d6f5c0df-6262-4704-bb24-430f66bb2ca8 2025-09-09 Warnings Exact identifier application number: M017 Blue-Emu Lidocaine Pain Relief Cream LIDOCAINE CREAM 4% Kingsway Pharmaceuticals dba NFI, LLC 592811f2-e21c-6a58-e053-2991aa0a69a9 2025-09-09 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Unifirst First Aid Corporation 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 2025-09-09 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