LidoStat

Product NDC: 44577-704
11-digit product format: 445770704
Labeler code: 44577
Product ID: 44577-704_0973ba09-954a-0fb9-e063-6294a90a4d13
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HCL
Dosage form: CREAM
Route: TOPICAL
Labeler: Clinical Therapeutic Solutions
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-06-19
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 40 mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: LidoStat
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	40 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1010895	Internal RxNorm lookup
1427002	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
1825885b-9141-4515-bb69-a1c4a39fb10d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44577-704-02	LidoStat	1 in 1 CARTON	CREAM	1		5
44577-704-02	LidoStat	56 g in 1 TUBE	CREAM	56		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
UREA	INACTIVE INGREDIENT	8W8T17847W	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44577-704	LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]	5	Current NDC, Legacy NDC, 2 package rows	20231106_1825885b-9141-4515-bb69-a1c4a39fb10d.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 82 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHYL SALICYLATE 25%	METHYL SALICYLATE	Oncora Pharma, LLC	3c4bc55d-6582-3b5e-e063-6394a90a994c	2025-08-13	Warnings	Exact identifier application number: M017
Lidocaine 3%	LIDOCAINE HCL 3%	PureTek Corporation	3bc94d52-fe52-9fd6-e063-6294a90a4340	2025-08-12	Warnings	Exact identifier application number: M017
Fast Freeze	MENTHOL	Natural Essentials Inc.	d8c42c8d-6ce0-43bf-b165-41979f3d8f79	2025-08-12	Warnings	Exact identifier application number: M017
Careland X-large Lidocaine 4 Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	a6867506-4a46-47b1-b5b6-bfedb59dfde6	2025-08-11	Warnings	Exact identifier application number: M017
Dermedial Anti-Ouch	MENTHOL	Saje Natural Business Inc.	3c194b8f-cfa5-11e3-e063-6394a90a92de	2025-08-11	Warnings	Exact identifier application number: M017
Thera Plus Extra Strength Muscle Rub Topical Analgesic	MENTHOL	FOURSTAR GROUP USA, INC.	8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	2025-08-11	Warnings	Exact identifier application number: M017
EARTHS CARE ARTHRITIS	CAPSAICIN	DLC Laboratories, Inc.	9460674b-057e-40b9-a0f9-ca3d92068d4f	2025-08-11	Warnings	Exact identifier application number: M017
LILAS PERIOD	MENTHOL	Lilas Wellness, Inc.	5ea53b4b-45e6-48a7-8090-09c3a21e7f63	2025-08-11	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Roll-On	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	31639407-0f11-bde2-e063-6294a90af694	2025-08-10	Warnings	Exact identifier application number: M017
Chinese Red Tiger Lidocaine Patches	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	20cd369c-3e98-3d8f-e063-6394a90a0824	2025-08-10	Warnings	Exact identifier application number: M017
Treatonic LIDOCAINE PAIN RELIEF	LIDOCAINE 4%	100 KARMA INC	3bd66b03-ac82-2d45-e063-6294a90a610a	2025-08-08	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Advanced Rx of Tennessee, LLC	3bdcef94-d06f-9152-e063-6294a90a6072	2025-08-08	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Advanced Rx of Tennessee, LLC	3bdd0c52-29d8-ab67-e063-6294a90a9c45	2025-08-08	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Advanced Rx of Tennessee, LLC	3bdd3015-349a-0fac-e063-6394a90afe41	2025-08-08	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Advanced Rx of Tennessee, LLC	3bdd6b3d-7180-288c-e063-6394a90a1785	2025-08-08	Warnings	Exact identifier application number: M017
Good Sense Pain Relief Roll On	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	38e76fd6-e5fb-493c-e063-6294a90afed4	2025-08-08	Warnings	Exact identifier application number: M017
Aruba Aloe Alcoholada	LIDOCAINE HYDROCHLORIDE	Aruba Aloe Balm NV	f56c62b0-75db-4499-858e-54e10b0e140a	2025-08-07	Warnings	Exact identifier application number: M017
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Exact identifier application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGE	SOOTHING PAIN RELIEF MASSAGE	Beijing JUNGE Technology Co., Ltd.	3524ad62-0ed6-f2e5-e063-6394a90a3283	2025-08-06	Warnings	Exact identifier application number: M017
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	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
1010895	lidocaine HCl 4 % Topical Cream	PSN	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1427002	Lidostat 4 % Topical Cream	PSN	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1427002	lidocaine hydrochloride 40 MG/ML Topical Cream [Lidostat]	SBD	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1010895	lidocaine hydrochloride 40 MG/ML Topical Cream	SCD	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1010895	lidocaine hydrochloride 4 % Topical Cream	SY	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1427002	Lidostat 4 % Topical Cream	SY	1825885b-9141-4515-bb69-a1c4a39fb10d	5
1427002	Lidostat 40 MG/ML Topical Cream	SY	1825885b-9141-4515-bb69-a1c4a39fb10d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44577-704-02	44577070402	1 TUBE in 1 CARTON (44577-704-02) / 56 g in 1 TUBE	1 tube	2017-02-07	0000-00-00	No	No	Current