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 152 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bactine Max Lidocaine Roll-on 2.5oz LIDOCAINE WellSpring Pharmaceutical Corporation 09b32a98-9131-451e-87a6-81a1e4ed7ec5 2023-04-25 Warnings Exact identifier application number: M017 Icy Hot Pro Dry CAMPHOR, MENTHOL Chattem, Inc. 4de1bc29-d166-4599-9e75-5f841bf20967 2023-03-01 Warnings Exact identifier application number: M017 Icy Hot Vanishing Scent MENTHOL Chattem, Inc. e2092016-9741-433d-92e6-74bfddadb72c 2022-09-29 Warnings Exact identifier application number: M017 New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Alexso, Inc 5dbd5fc0-a27e-4979-aca7-28f73096fd5f 2022-08-18 Warnings Exact identifier application number: M017 FIRSTAR Sting Relief Pad BENZOCAINE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 0e491a7a-4204-439f-862d-741cbc0be9fd 2021-07-06 Warnings Exact identifier application number: M017 Arthritis Relief GoodSense TROLAMINE SALICYLATE Geiss, Destin & Dunn, Inc a253730a-2187-07de-e053-2a95a90a9877 2020-04-02 Warnings Exact identifier application number: M017 Aloe Cort HYDROCORTISONE Topiderm, Inc. 789a6669-3320-4558-8d6f-ab255db50d8d 2019-09-17 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 567b6820-fb52-630e-e063-6294a90a8bf8 2015-07-01 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Aromatic CAMPHOR, MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 54e45d89-e8c3-6fc3-e063-6394a90aac4e 2015-06-15 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