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 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 27 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPARTAN LIDOCAINE TIV PRIME SRL 4e04146a-ed19-2271-e063-6394a90a50f0 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Lidocaine LIDOCAINE Walgreen Co. 41d5bdc4-66c8-31ab-e063-6394a90a1195 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch LIDOCAINE, MENTHOL Walgreen Co. 41d64a88-90fc-27ca-e063-6294a90a602b 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated CAMPHOR, MENTHOL The Mentholatum Company 4e05d134-6c7f-1501-e063-6294a90ad27d 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Patch XL MENTHOL Walgreen Co. 41e92435-7f77-a593-e063-6394a90a4b38 2026-03-27 Warnings Exact identifier application number: M017 Walgreens Cool N Heat Back Patch MENTHOL Walgreen Co. 41e81110-4b79-1fa6-e063-6394a90ae90c 2026-03-27 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Elderberry Acai CAMPHOR, MENTHOL The Mentholatum Company 4e0743a6-d450-043b-e063-6394a90ad1c2 2026-03-27 Warnings Exact identifier application number: M017 QFSN Pain Relief Cream PAIN RELIEF CREAM Qiaofusheng Pharmaceuticals Co., Ltd. 4d215da1-87f5-d35d-e063-6394a90ac348 2026-03-27 Warnings Exact identifier application number: M017 FlexSport Roll On METHYL SALICYLATE Pharmadel LLC bf8de3da-7628-6112-e053-2995a90a8e16 2026-03-26 Warnings Exact identifier application number: M017 Kofal Original METHYL SALICYLATE Pharmadel LLC 984780fd-496b-150b-e053-2995a90aed77 2026-03-26 Warnings Exact identifier application number: M017 Kofal Fuerte METHYL SALICYLATE Pharmadel LLC 98488a07-eba0-2b4e-e053-2995a90ad6ab 2026-03-26 Warnings Exact identifier application number: M017 Kofal Max Power MENTHOL Pharmadel LLC fe1f1408-b0cb-67a4-e053-6394a90ad609 2026-03-26 Warnings Exact identifier application number: M017 Kofal METHYL SALICYLATE Pharmadel LLC 9cac377d-97bc-f0b7-e053-2a95a90a2e12 2026-03-26 Warnings Exact identifier application number: M017 Milagroso CAMPHOR Pharmadel LLC 12b0401c-84d5-07cd-e063-6394a90a052c 2026-03-26 Warnings Exact identifier application number: M017 Ubredol METHYL SALICYLATE Pharmadel LLC fe96eead-1722-c05d-e053-6394a90a850f 2026-03-26 Warnings Exact identifier application number: M017 DZUL PAIN FREEZE INSTANT PAIN RELIEF MENTHOL Caball Sales, Inc. 4df3abcc-17f3-17f2-e063-6294a90afcca 2026-03-26 Warnings Exact identifier application number: M017 Equate Cool and Heat Extra Strength MENTHOL Wal-Mart Stores Inc ca3088a7-e1ec-4e69-80d9-fd0051bde938 2026-03-25 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 2ea95529-ec4b-c2ce-e063-6394a90a0739 2026-03-25 Warnings Exact identifier application number: M017 NUMBING CREAMS MENTHOL LIDOCAINE Yongchun Lihui Trading Co., Ltd. 4dd38cdf-d644-6da0-e063-6294a90afb3d 2026-03-25 Warnings Exact identifier application number: M017 ANTIPHLAMINE L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE Masaem Company 4dd3ab12-6cd3-1060-e063-6394a90a2dec 2026-03-25 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