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 2026-12-31
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 2026-12-31 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 19 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 3f2b1f48-2d78-4985-a046-9f72de5e1a9b 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 10a8face-47da-ebbe-e063-6294a90a42fe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Cream MENTHOL Reckitt Benckiser LLC 32450cbf-4ed4-402b-a30e-e08a17bba3fb 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC a227213b-e89f-7144-e053-2a95a90a7e74 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 00bb462a-27d0-6f74-e063-6394a90a90ec 2026-05-13 Warnings Exact identifier application number: M017 BioFreeze Dry Stick MENTHOL Reckitt Benckiser LLC 26d62cd2-9209-8cca-e063-6394a90a2028 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Pain Relief Set MENTHOL Reckitt Benckiser LLC 4a885eef-0364-4655-bccc-7158c76cc5b2 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless Roll-On MENTHOL Reckitt Benckiser LLC a8d59d45-0e85-43d1-affd-bbe922c4acb1 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless MENTHOL Reckitt Benckiser LLC 939dbbc3-71ec-4990-840e-7c9b8d430562 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Flexible Relief Strip MENTHOL Reckitt Benckiser LLC 6ec26bae-e395-49aa-969e-8c653d6f0b27 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Day and Overnight MENTHOL Reckitt Benckiser LLC fb5c8f89-a720-ad32-e053-6294a90a2abe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foam MENTHOL Reckitt Benckiser LLC 890191e8-99ad-489c-8f21-2592f3d31936 2026-05-13 Warnings Exact identifier application number: M017 Orajel Cold Sore Touch Free - Single Dose BENZALKONIUM CHLORIDE, BENZOCAINE Church & Dwight Co., Inc. ce40829e-941f-2548-e053-2995a90a1e0e 2026-05-13 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE GERI-CARE PHARMACEUTICAL CORP 51b7753b-8619-6ea9-e063-6294a90a4ea4 2026-05-13 Warnings Exact identifier application number: M017 DERMFREE Anti-itch Cream HYDROCORTISONE1% ANTI-ITCH CREAM Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. 519c319a-9c43-0e63-e063-6394a90ab869 2026-05-13 Warnings Exact identifier application number: M017 Valtrum TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE Laboratorios Quantium LLC f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM Reckitt Benckiser 4639201c-a67a-475f-8df6-3dc6225803ad 2026-05-12 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC bae9946a-4c68-4759-9fb3-0a61a7ad0eb7 2026-05-12 Warnings Exact identifier application number: M017 Instaflex Pain Relief Cream MENTHOL Healthy Directions, LLC 665b847a-9cfb-49fc-975b-81c97f936575 2026-05-12 Warnings Exact identifier application number: M017 Theracare Cold Therapy Pain Relief MENTHOL Veridian Healthcare 51a5a043-07b6-1c96-e063-6394a90aa926 2026-05-12 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