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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

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
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 63 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger	3f881349-fcdd-e276-e063-6394a90ae49e	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434cb8b2-a996-5360-e063-6394a90ada03	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	4360e3ec-7a4b-b28e-e063-6294a90a0bd6	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	4360e3be-0ec4-cd57-e063-6394a90aca63	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	43616ad7-58bb-e5ad-e063-6394a90a192b	2025-11-13	Warnings	Exact identifier application number: M017
4x Medicated Severe Toothache and Gum Gel	BENZALKONIUM CHLORIDE	Meijer	97ce7890-5093-1763-e053-2a95a90afae7	2025-11-13	Warnings	Exact identifier application number: M017
Pain Reliever	CAMPHOR, MENTHOL	Kool 'N Fit Inc.	2253f6bd-5707-b993-e063-6394a90aa74a	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	4360e0d1-46cd-ab4b-e063-6394a90a55e1	2025-11-12	Warnings	Exact identifier application number: M017
CVS Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	CVS	8723e097-296f-784a-e053-2991aa0a552e	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154d8821-3e76-b0e2-e063-6294a90ae077	2025-11-12	Warnings	Exact identifier application number: M017
Good neighbor Pharmacy Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	AMERISOURCEBERGEN DRUG CORPORATION	87395273-380c-7cef-e053-2991aa0a54c6	2025-11-12	Warnings	Exact identifier application number: M017
Quality Choice Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Chain Drug Marketing Association	8735b298-83f3-0b5d-e053-2a91aa0a8292	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	1550e794-b3c0-4769-e063-6294a90a8c2d	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154fd46e-f00d-1772-e063-6394a90aba7d	2025-11-12	Warnings	Exact identifier application number: M017
Best Choice Itch Stopping	DIPHENHYDRAMINE HCL	Valu Merchandisers	884cfd64-2cd1-8c12-e053-2995a90a8925	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	CVS	8839149d-e6d5-57cc-e053-2995a90a9832	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	Chain Drug Marketing Association	884c9b47-d511-1d17-e053-2995a90a42eb	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 1	BENZOCAINE	Sambria Pharmaceuticals, LLC	2f8fdcac-b87a-4191-9504-480a473f95cc	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 2	LIDOCAINE	Sambria Pharmaceuticals, LLC	180b2899-7699-40e2-974a-081a6ce2bca2	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 3	TETRACAINE	Sambria Pharmaceuticals, LLC	9c24dcff-3988-40eb-821a-fd4b0c85f528	2025-11-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1009433	lidocaine HCl 2.5 % Topical Gel	PSN	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	4
1009433	lidocaine hydrochloride 0.025 MG/MG Topical Gel	SCD	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	4
1009433	lidocaine hydrochloride 2.5 % Topical Gel	SY	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	4

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