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 130 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 Warnings Exact identifier application number: M017 Relief MENTHOL La Mend, Inc. 1f92de3a-7180-5884-e063-6294a90aebf5 2024-08-01 Warnings Exact identifier application number: M017 Meijer Medicated Foot Powder MENTHOL Meijer Distribution 07ec6c20-73c4-e5e4-e063-6294a90a7e55 2024-07-29 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. e05ec3b7-e9ab-4eaa-8518-86304336697c 2024-07-29 Warnings Exact identifier application number: M017 Walgreens Roll-On CAPSAISIN 0.1% Walgreens Co 1e65bf31-15c7-5e6a-e063-6394a90ac956 2024-07-29 Warnings Exact identifier application number: M017 Camphotrex CAMPHOR, MENTHOL PureTek Corporation 3b6c6eef-e92d-497d-afe8-82356637c2b8 2024-07-26 Warnings Exact identifier application number: M017 Camphotrol CAMPHOR, MENTHOL PureTek Corporation ccac9f37-a374-4765-e053-2a95a90ad2f7 2024-07-26 Warnings Exact identifier application number: M017 Real Time Pain Relief Foot MENTHOL Real Time Products Inc. 29c8e06d-9b29-44f9-ac21-9160d06475cb 2024-07-24 Warnings Exact identifier application number: M017 Capsaicin 0.075 Percent CAPSAICIN Alexso, Inc 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd 2024-07-22 Warnings Exact identifier application number: M017 TIDL Pain Relief CRYO Therapy Limited Edition PAIN RELIEF CRYO THERAPY LIMITED EDITION Shenzhen Sam Technology Co., Ltd. 1d966b67-fd9c-eab6-e063-6294a90aa75e 2024-07-19 Warnings Exact identifier application number: M017 Fruit of the Earth Aloe Vera Cool Blue LIDOCAINE HYDROCHLORIDE Fruit of the Earth, Inc. 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 2024-07-19 Warnings Exact identifier application number: M017 Ultra Balm MENTHOL AND METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. de997baf-aa04-474e-b912-3fc67e720d0b 2024-07-19 Warnings Exact identifier application number: M017 Ling Nam Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. 3f16cce3-366f-41f3-8829-6de4082a8c19 2024-07-19 Warnings Exact identifier application number: M017 Koong Yick Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. bc33e185-3b42-98b5-e053-2995a90a6308 2024-07-18 Warnings Exact identifier application number: M017 Koong Yick Hung Fa METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. 9c8a121d-6da2-4435-a2d7-a0b71d10740d 2024-07-18 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