Lidocaine Hydrochloride

Product NDC: 61010-5100
11-digit product format: 610105100
Labeler code: 61010
Product ID: 61010-5100_114b1a82-0728-fe2e-e063-6394a90a309e
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-02
Substance: LIDOCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	61010-5100		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61010-5100	61010-5100-3	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Lidocaine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	20 mg/mL

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
1010769	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
8eb3e7e2-26e5-430e-89aa-40a0367c637e	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61010-5100-3	2024-02-13	61010-5100, Burn Spray
61010-5100-4	2024-02-13	61010-5100, Burn Spray
61010-5100-5	2024-02-13	61010-5100, Burn Spray
61010-5100-3	2024-01-30	61010-5100, Burn Spray
61010-5100-4	2024-01-30	61010-5100, Burn Spray
61010-5100-5	2024-01-30	61010-5100, Burn Spray
61010-5100-3	2020-03-10	61010-5100, Burn Spray
61010-5100-3	2020-01-31	61010-5100, Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-5100-4	Lidocaine Hydrochloride	59.1 mL in 1 BOTTLE, SPRAY	LIQUID	59.1		7
61010-5100-5	Lidocaine Hydrochloride	118 mL in 1 BOTTLE, SPRAY	LIQUID	118		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lidocaine Hydrochloride	ACTIVE INGREDIENT	V13007Z41A	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4
Lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5100	LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240214_8eb3e7e2-26e5-430e-89aa-40a0367c637e.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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
T-Relief Lidocaine HCL 4%	LIDOCAINE HCL 4%	Medinatura New Mexico Inc.	3c19aff8-fb18-78d0-e063-6294a90a9481	2025-12-11	Warnings	Exact identifier application number: M017
Jointiva	TROLAMINE SALICYLATE 10%	Rising Pharma Holdings, Inc.	3ee33cbf-7c0f-4982-b0b6-eeeb0202803b	2025-12-11	Warnings	Exact identifier application number: M017
LMX4	LIDOCAINE	Ferndale Laboratories, Inc.	f0e7c92f-8b0b-4045-b659-af9f6e81260f	2025-12-10	Warnings	Exact identifier application number: M017
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	45811e83-8d0b-bc2a-e063-6294a90adf50	2025-12-09	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	4580d7f0-92a9-d0d0-e063-6394a90ac393	2025-12-09	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ALAINA HEALTHCARE PRIVATE LIMITED	c339dffe-bc9b-4fae-a50f-8db463d244c1	2025-12-09	Warnings	Exact identifier application number: M017
Capsaicin Cream 0.075%	CAPSAICIN	ALAINA HEALTHCARE PRIVATE LIMITED	33e861bd-bb92-4aea-9d4d-1b8847c794fd	2025-12-09	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	ALAINA HEALTHCARE PRIVATE LIMITED	e07c5ebc-5497-4c45-acc5-d12e72e98f3f	2025-12-09	Warnings	Exact identifier application number: M017
Ultra Strength Pain Relief Balm	CAMPHOR, MENTHOL	ALAINA HEALTHCARE PRIVATE LIMITED	80779d1f-0c2a-4ae5-9ed7-eb6877f734ba	2025-12-09	Warnings	Exact identifier application number: M017
Pain Relief Balm	MENTHOL AND CAMPHOR	ALAINA HEALTHCARE PRIVATE LIMITED	12d76b8f-4b1d-4f2d-9722-0adb55093cc4	2025-12-09	Warnings	Exact identifier application number: M017
Trojan Extended Pleasure	BENZOCAINE	Church & Dwight Co., Inc.	be731682-4174-649a-e053-2a95a90a3987	2025-12-09	Warnings	Exact identifier application number: M017
Stopain Clinical Continuous	MENTHOL	Troy Manufacturing, Inc.	65f8d212-0f0e-4893-b6af-bd68bba46443	2025-12-09	Warnings	Exact identifier application number: M017
Pain and Itch Relief 4% Lidocaine	LIDOCAINE	Walgreens	f84e76a9-6af6-4fd1-be4e-efa05728cbfd	2025-12-09	Warnings	Exact identifier application number: M017
Capsimide	CAPSAICIN 0.025% TOPICAL PATCH	Sola Pharmaceuticals	e81c2de8-6429-d681-e053-2995a90a36a9	2025-12-08	Warnings	Exact identifier application number: M017
Extra Strength Cold-Hot Medicated Patches	MENTHOL	Cardinal Health, 110 dba LEADER	a2895c03-747c-4220-8052-4f0428062622	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	5feae39e-3ab8-4cda-b9e8-dc221aea2417	2025-12-08	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	f8837b69-8d85-448c-a4b4-be911bca1f6c	2025-12-08	Warnings	Exact identifier application number: M017
CAPSAICIN HOT PATCHES	CAPSAICIN	Cardinal Health, 110 dba LEADER	76e6bc39-643c-4264-8d98-0e4fa7d778e2	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	3be6defd-f429-4dc7-8b37-5910705c0b81	2025-12-08	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
1010769	lidocaine HCl 2 % Topical Spray	PSN	8eb3e7e2-26e5-430e-89aa-40a0367c637e	7
1010769	lidocaine hydrochloride 20 MG/ML Topical Spray	SCD	8eb3e7e2-26e5-430e-89aa-40a0367c637e	7
1010769	lidocaine hydrochloride 2 % Topical Spray	SY	8eb3e7e2-26e5-430e-89aa-40a0367c637e	7
1010769	lidocaine HCl 2 % Topical Spray	PSN	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	3
1010769	lidocaine hydrochloride 20 MG/ML Topical Spray	SCD	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	3
1010769	lidocaine hydrochloride 2 % Topical Spray	SY	f1f051ad-7e82-9d1a-e053-2a95a90ac7d3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-5100-4	61010510004	59.1 mL in 1 BOTTLE, SPRAY (61010-5100-4)	59.1 ml	2011-08-02	0000-00-00	No	No	Current
61010-5100-5	61010510005	118 mL in 1 BOTTLE, SPRAY (61010-5100-5)	118 ml	2011-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Only Burn Spray	Acme United Corporation	2024-11-12	HUMAN OTC DRUG LABEL	3
61010-5100, Burn Spray	Safetec of America, Inc.	2024-02-07	HUMAN OTC DRUG LABEL	7