Calm and Correct Serum with Lidocaine

Product NDC: 76348-725
11-digit product format: 763480725
Labeler code: 76348
Product ID: 76348-725_34b77b18-b7e3-c3e3-e063-6294a90aead8
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine 3 percent
Dosage form: LIQUID
Route: TOPICAL
Labeler: Renu Laboratories, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-02
Substance: LIDOCAINE
Active strength: 1.5 g/50mL
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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76348-725-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76348-725-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76348-725-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-725-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-725-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-725-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-725-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Calm and Correct Serum with Lidocaine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	1.5 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2607527	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
ddcf1c2e-2f67-44d7-e053-2a95a90a812b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-725-01	2025-05-12	C162847	48780-1	2cef2736-67f1-d83d-e063-dadaa90ab31f	CALM and CORRECT PAIN RELIEF SERUM
76348-725-01	2025-01-30	C162847	48780-1	2cef2736-67f1-d83d-e063-dadaa90ab31f	CALM and CORRECT PAIN RELIEF SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-725-01	Calm and Correct Serum with Lidocaine	1 in 1 BOX	LIQUID	1		2
76348-725-50	Calm and Correct Serum with Lidocaine	50 mL in 1 BOTTLE, PUMP	LIQUID	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-725	CALM AND CORRECT SERUM WITH LIDOCAINE (LIDOCAINE 3 PERCENT) LIQUID [RENU LABORATORIES, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20250514_ddcf1c2e-2f67-44d7-e053-2a95a90a812b.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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burn First Aid	BURN FIRST AID	Dynarex Corporation	826e08be-dffa-5a27-e053-2a91aa0a8701	2024-01-22	Warnings	Exact identifier application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On	MENTHOL	TARGET CORPORATION	0f95fc55-8665-9e89-e063-6394a90a7891	2024-01-22	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief Plus Menthol	LIDOCAINE, MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	77978069-a1b4-473e-83c9-8320e00eea89	2024-01-19	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMPS	CAMPHOR, MENTHOL	KOBAYASHI Healthcare International, Inc.	ba26635d-95d3-4d88-93cc-1fd4fd29fd79	2024-01-18	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	e95ebdac-9789-41c2-97da-2307e4538794	2024-01-18	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE	Unifirst First Aid Corporation	bd216f5d-f304-7d8d-e053-2a95a90aa9ce	2024-01-17	Warnings	Exact identifier application number: M017
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Exact identifier application number: M017
Pain Relief	LIDOCAINE, MENTHOL	HUMN Pharmaceuticals Inc	6c96f94a-e724-eab3-e053-2991aa0aab88	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief	LIDOCAINE	Natural Essentials, Inc.	52e82e70-53b7-4ecb-be39-fe10c94cc444	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health XL Lidocaine Pain Relief	LIDOCAINE	NATURAL ESSENTIALS, INC.	ec16da91-8244-402b-b8d8-84896094ac2c	2024-01-17	Warnings	Exact identifier application number: M017
Anti-itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Target Corporation	f444b0a6-2ed3-4236-8206-342150290675	2024-01-17	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Anti-itch	HYDROCORTISONE 1%	Target Corporation	4ff39cb8-3a20-4fe7-9829-1e882a484668	2024-01-17	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Exact identifier application number: M017
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier application number: M017
FIRST SHIELD	LIDOCAINE HCI	Ever Ready First Aid	e022bf8f-3dd8-de22-e053-2995a90a219b	2024-01-15	Warnings	Exact identifier application number: M017
Flexigen	MENTHOL 1.25%	Derma Care Research Labs, LLC	e9ae2682-59b4-e796-e053-2995a90af921	2024-01-15	Warnings	Exact identifier application number: M017
Vita-P Oral and Nasal	MENTHOL 1%	Beijing HKKY Medical Tech. Co., Ltd.	537c3843-1c92-41c6-b724-52701bbddeab	2024-01-13	Warnings	Exact identifier application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2607527	lidocaine 3 % Topical Solution	PSN	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2
2607527	lidocaine 30 MG/ML Topical Solution	SCD	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2
2607527	lidocaine 3 % Topical Solution	SY	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-725-01	76348072501	1 BOTTLE, PUMP in 1 BOX (76348-725-01) / 50 mL in 1 BOTTLE, PUMP (76348-725-50)		2022-08-02	0000-00-00	No	No	Current
76348-725-50	76348072550	50 mL in 1 BOTTLE, PUMP	50 ml					Historical