Home NDC 55621-010 Assured
Product NDC 55621-010
11-digit product format 556210010
Labeler code 55621
Product ID 55621-010_0884b4eb-7fc4-b2c7-e063-6294a90aa02e
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form GEL
Route TOPICAL
Labeler Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-30
Substance LIDOCAINE HYDROCHLORIDE
Active strength 2.5 g/100g
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 Assured
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 2.5 g/100g
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 1009433 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55621-010-01 Assured 1 in 1 BOX GEL 1 4 55621-010-01 Assured 20 g in 1 TUBE GEL 20 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE HYDROCHLORIDE ACTIVE INGREDIENT V13007Z41A ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 LIDOCAINE ACTIVE MOIETY 98PI200987 ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 4Q93RCW27E ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55621-010 ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.] 4 Current NDC, Legacy NDC, 2 package rows 20231025_ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c.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 72 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine 4% Maximum OTC Strength LIDOCAINE Cardinal Health 107, LLC 975031df-d46d-4098-b1c0-1c0c92b41995 2025-10-20 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing HYDROCORTISONE Chattem, Inc. bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c 2025-10-20 Warnings Exact identifier application number: M017 Sting relief pad BENZOCAINE, ALCOHOL Guangdong Comfort Medical Products Co., Ltd. 6e905065-10a9-1ded-e053-2a91aa0a46a1 2025-10-19 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44cec95-822a-40b6-e053-2995a90ae31c 2025-10-17 Warnings Exact identifier application number: M017 Sombra Max SOMBRA MAX Sombra Cosmetics Inc. 41623a46-e6e7-907e-e063-6394a90afc4c 2025-10-17 Warnings Exact identifier application number: M017 POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE TELEVISA CONSUMER PRODUCTS USA c283291d-feaa-4f89-8fde-9e3957ea8b9f 2025-10-17 Warnings Exact identifier application number: M017 Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 414217c1-ff3a-b556-e063-6394a90aa5db 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41422d04-160b-51b2-e063-6294a90ab2b2 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41427275-4c35-bbdf-e063-6294a90a14cf 2025-10-16 Warnings Exact identifier application number: M017 Dollar General Menthol Pain Relief Gel Rollon MENTHOL Dolgencorp, LLC 3a9b99e2-36b8-5dcf-e063-6394a90a382d 2025-10-16 Warnings Exact identifier application number: M017 Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Exact identifier application number: M017 DentiCalm TOPICAL ANALGESIC NFUSE LLC 414e6f6f-06bb-b470-e063-6294a90af390 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 413008cd-d239-1453-e063-6394a90a74f2 2025-10-15 Warnings Exact identifier application number: M017 PERFORM LEO EXTENSIVE PAIN RELIEF LIDOCAINE, MENTHOL PERFORM LEO LLC f993ed5f-7dbb-4e3e-addf-f65b12f5cc48 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Lower Leg Sleeve CAPSAICIN Nufabrx LLC b8e3e528-b7cd-e4b7-e053-2995a90a4029 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Ankle Sleeve CAPSAICIN Nufabrx LLC 013d60c7-a613-7cdf-e063-6294a90ad584 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Calf Sleeve CAPSAICIN Nufabrx LLC bd9459c4-5596-746f-e053-2995a90a5400 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Arm Sleeve CAPSAICIN Nufabrx LLC a7993eaf-6488-a818-e053-2995a90a7ea6 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Back Wrap CAPSAICIN Nufabrx LLC e4f85ac8-57cb-46eb-e053-2995a90a9b1c 2025-10-15 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 55621-010-01 55621001001 1 TUBE in 1 BOX (55621-010-01) / 20 g in 1 TUBE 1 tube 2014-10-30 0000-00-00 No No Current