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 152 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Exact identifier application number: M017
Icy Hot Pro Dry	CAMPHOR, MENTHOL	Chattem, Inc.	4de1bc29-d166-4599-9e75-5f841bf20967	2023-03-01	Warnings	Exact identifier application number: M017
Icy Hot Vanishing Scent	MENTHOL	Chattem, Inc.	e2092016-9741-433d-92e6-74bfddadb72c	2022-09-29	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier application number: M017
FIRSTAR Sting Relief Pad	BENZOCAINE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	0e491a7a-4204-439f-862d-741cbc0be9fd	2021-07-06	Warnings	Exact identifier application number: M017
Arthritis Relief GoodSense	TROLAMINE SALICYLATE	Geiss, Destin & Dunn, Inc	a253730a-2187-07de-e053-2a95a90a9877	2020-04-02	Warnings	Exact identifier application number: M017
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	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