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 61 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	fc8a8f20-97ab-481e-e053-6394a90a3525	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF ROLL-ON 3OZ	934d4638-b47b-187d-e053-2995a90ae69d	2025-11-20	Warnings	Exact identifier application number: M017
FOOT PAIN RELIEF ROLL-ON	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	43edcea0-ab04-f368-e063-6294a90a817a	2025-11-19	Warnings	Exact identifier application number: M017
Absolut Skin Corticosoothe Anti-Itch	HYDROCORTISONE	Absolut Skin Incorporated	deb52218-9176-4aaa-a22f-b66dada6690f	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	43f3d189-f6b7-02ed-e063-6394a90afd73	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2Z	LIDOCAINE	InterMed Laboratories Private Limited	43f3e288-e828-8130-e063-6394a90a6d44	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Leader	LIDOCAINE	InterMed Laboratories Private Limited	42f06914-c8b8-ea9c-e063-6294a90a79e6	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	CAMPHOR, MENTHOL	CVS	87715662-c788-9a8d-e053-2a95a90acb53	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti Itch	CAMPHOR, MENTHOL	Walgreens	b4f47a8d-d4a6-9233-e053-2a95a90afd90	2025-11-19	Warnings	Exact identifier application number: M017
Leader Anti-Itch	CAMPHOR, MENTHOL	LEADER/Cardinal Helath 110, Inc.	9ca985c6-5017-0558-e053-2995a90a8202	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	PRAMOXINE HCL	CVS	87fc476a-5b12-7383-e053-2995a90a530b	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti-Itch	PRAMOXINE HCL	Walgreens	b5f9d1c5-891e-4377-e053-2995a90aa281	2025-11-19	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	89f5f688-856f-f2df-e053-2995a90a73cf	2025-11-19	Warnings	Exact identifier application number: M017
Itch Eraser	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	2204e135-6a23-68a2-e063-6394a90ac019	2025-11-18	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	c8594e10-661f-6ff3-e053-2995a90ab4fc	2025-11-18	Warnings	Exact identifier application number: M017
Mag 5 PT Cooling Formula Recovery Cream	MENTHOL	RENU LABORATORIES, LLC	a45cde67-64ec-643b-e053-2a95a90a10b6	2025-11-18	Warnings	Exact identifier application number: M017
After Ivy Wipe	CAMPHOR	Tender Corporation d/b/a Adventure Ready Brands	21d98018-826a-1d0d-e063-6294a90a0a71	2025-11-17	Warnings	Exact identifier application number: M017
Itch Eraser Gel	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	223c7cfd-6dc5-140a-e063-6394a90a8332	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Kroger Co.	6b3e7aac-395f-48cf-9c5e-f7e163724aef	2025-11-17	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	HY-VEE, INC	415ecfe9-3145-f23e-e063-6394a90adfd8	2025-11-17	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