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 111 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Meijer Distribution Inc 75c6fcd5-185c-4203-b604-19ce801c865f 2024-12-18 Warnings Exact identifier application number: M017 MEIJER PAIN RELIEF PATCHES LIDOCAINE Meijer Distribution Inc aa5da66d-3ba9-4120-be35-44bec475761a 2024-12-18 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Roll-On LIDOCAINE 4% CVS Pharmacy 8a9757e3-0bfc-a1e2-e053-2a95a90a6da3 2024-12-18 Warnings Exact identifier application number: M017 Dollar General Cold-Hot Medicated Patches MENTHOL DOLGENCORP, LLC c6e0388b-af9e-4e51-8f94-6788185c31a0 2024-12-18 Warnings Exact identifier application number: M017 THERA CARE PAIN THERAPY LIDOCAINE Veridian Healthcare e023bb5a-a4bc-4681-a1f4-48ca0d2cb102 2024-12-18 Warnings Exact identifier application number: M017 TheraCare Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Veridian Healthcare f6f3c9c0-d6e3-75a3-e053-6294a90a1965 2024-12-18 Warnings Exact identifier application number: M017 Good Sense Hot and Cold Medicated Patch MENTHOL GOOD SENSE 1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e 2024-12-18 Warnings Exact identifier application number: M017 Hunter Beach 4% LIDOCAINE HUNTERS BEACH LIFE f2ef9c12-6e42-486b-b6f2-0ad534e94294 2024-12-18 Warnings Exact identifier application number: M017 Hunter Beach 4% LIDOCAINE HUNTERS BEACH LIFE 05a9605b-0d01-4333-8e54-7202e7c31c49 2024-12-18 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE The Mentholatum Company 32b64985-0e2f-49ee-9840-946d7279fee7 2024-12-17 Warnings Exact identifier application number: M017 WellPatch Warming Pain Relief CAPSAICIN The Mentholatum Company ec583129-55fc-4ab1-94e5-9c900b5d95ef 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Cold and Hot Pain Relieving Extra Strength MENTHOL, METHYL SALICYLATE CVS Pharmacy 1ca1a631-cb2c-46cd-bd41-05469b08d208 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Pain Relieving MENTHOL, METHYL SALICYLATE The Mentholatum Company 0056b952-9870-485a-9f35-f985472875a9 2024-12-17 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Heat LIDOCAINE HCL The Mentholatum Company cc2ef25a-b569-4d48-a666-899f710b4b34 2024-12-17 Warnings Exact identifier application number: M017 Rite Aid Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE Rite Aid Corporation 039fff40-b5ba-42cb-932c-8a70ca92759d 2024-12-17 Warnings Exact identifier application number: M017 Signature Care Cold and Hot Medicated MENTHOL Safeway 88f59f95-0a7c-458c-949c-0dff16ad94e4 2024-12-17 Warnings Exact identifier application number: M017 Equate Cool and Heat MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc c5ab2426-eeca-4ba4-9f00-7790d2176471 2024-12-17 Warnings Exact identifier application number: M017 Equate Capsaicin Pain Relieving CAPSAICIN Wal-Mart Stores Inc 745b2cf5-2599-4383-818b-19fed248a11f 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a 2024-12-17 Warnings Exact identifier application number: M017 DG Health Maximum Strength Pain Relieving Cleansing BENZALKONIUM CL, LIDOCAINE HCL Dollar General Corporation 64f69315-77a3-49dc-940d-efd7a29c6645 2024-12-17 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