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 2026-12-31 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 44 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tetracaine TETRACAINE Bellus Medical, LLC 60cabb5f-606b-7a74-e053-2a91aa0ac024 2026-01-09 Warnings Exact identifier application number: M017 Benzocaine BENZOCAINE Bellus Medical, LLC 60cafbaf-8ec6-46a5-e053-2a91aa0af11f 2026-01-09 Warnings Exact identifier application number: M017 PRAX PRAMOXINE HYDROCHLORIDE AvPAK dc646399-91ba-5cc1-e053-2a95a90a4f9c 2026-01-09 Warnings Exact identifier application number: M017 2.5% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC c842544a-6aea-42af-a77e-7b202371b387 2026-01-09 Warnings Exact identifier application number: M017 4% Menthol PAIN RELIEF MENTHOL Universal Distribution Center LLC 7fb95135-4151-4ef4-bb6d-75251cafff6c 2026-01-09 Warnings Exact identifier application number: M017 Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE Meijer Distribution, Inc 781f89c0-94ab-48de-9e0b-decb37bcde46 2026-01-09 Warnings Exact identifier application number: M017 LIDOCAINE PAIN RELIEVING Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 2159fb73-cf6c-184a-e063-6394a90a1d14 2026-01-08 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 22d9ce20-1cb6-c5bd-e063-6394a90a9eca 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INT'L THERMO ANALGETICS ROLL-ON 76ef713b-e23d-7b98-e053-2991aa0aad51 2026-01-08 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0ca84-2800-d222-e053-2995a90ad8f3 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5b0db6-8f0a-4f8e-e053-2995a90a22b7 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin Topical Analgesic CAPSAICIN AvPAK ef597423-cd01-7324-e053-2a95a90aa1ba 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN AvPAK ef5a3846-1d2f-7023-e053-2a95a90ad716 2026-01-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN AvPAK ef5bb0fa-afc2-62d7-e053-2a95a90a37f4 2026-01-08 Warnings Exact identifier application number: M017 K2 Cold Therapy MENTHOL The Podiatree Co 60dce1ad-125e-396d-e053-2a91aa0a670f 2026-01-08 Warnings Exact identifier application number: M017 Burn Relief Aloe LIDOCAINE HCL Acutens 48c435fe-2670-4b80-bf01-923dc9354422 2026-01-08 Warnings Exact identifier application number: M017 Relieve A Pain LIDOCAINE Relieve A Pain LLC cafaa830-d894-4590-8928-d579cc791d79 2026-01-08 Warnings Exact identifier application number: M017 DZUL ARTHRITIS PAIN RELIEF MENTHOL Caball Sales, Inc. 159c301c-d462-bb2c-e063-6394a90a9e5a 2026-01-08 Warnings Exact identifier application number: M017 DZUL - LIDO CREME LIDOCAINE HCL, MENTHOL Caball Sales, Inc. 063387e4-a1b1-a467-e063-6294a90a6cbd 2026-01-08 Warnings Exact identifier application number: M017 TOPICAINE LIDOCAINE 4% ESBA LABORATORIES INC. 7f96e980-891e-743d-e053-2a91aa0aea5f 2026-01-08 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