DermaRad Relief

Product NDC: 76348-720
11-digit product format: 763480720
Labeler code: 76348
Product ID: 76348-720_347e1804-127a-52a4-e063-6394a90ad676
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine Emulsion
Dosage form: EMULSION
Route: TOPICAL
Labeler: RENU LABORATORIES, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-03
Substance: ALLANTOIN; LIDOCAINE
Active strength: 1.18; 4.72 g/118mL; g/118mL
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 · 16 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	76348-720-01	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	76348-720-01	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	76348-720-01	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	76348-720-01	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	76348-720-01	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	76348-720-01	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	76348-720-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76348-720-01	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`

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: DermaRad Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLANTOIN	1.18 g/118mL
LIDOCAINE	4.72 g/118mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
344S277G0Z	Internal UNII lookup
98PI200987	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d5e11f73-918b-eeac-e053-2995a90a4a83	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-720-01	2025-05-07	C162847	48780-1	2cef2736-8a46-d83d-e063-dadaa90ab31f	DermaRad Relief Topical Rehydrating Emulsion
76348-720-01	2025-01-30	C162847	48780-1	2cef2736-8a46-d83d-e063-dadaa90ab31f	DermaRad Relief Topical Rehydrating Emulsion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-720-01	DermaRad Relief	1 in 1 BOX	EMULSION	1		7
76348-720-04	DermaRad Relief	118 mL in 1 TUBE	EMULSION	118		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-720	DERMARAD RELIEF (LIDOCAINE EMULSION) EMULSION [RENU LABORATORIES, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250508_d5e11f73-918b-eeac-e053-2995a90a4a83.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 116 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Menthol	MENTHOL 4%	Safeway	27d3cb47-a6c7-5b7a-e063-6394a90a056f	2024-12-05	Warnings	Exact identifier application number: M017
ITCH X	BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE	BF ASCHER AND CO INC	03c16d33-8f59-0184-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M017
PO First Aid Series BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	f1c349a8-216d-4233-922e-c95329a33d1e	2024-12-05	Warnings	Exact identifier application number: M017
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Exact identifier application number: M017
CBD Pain Relief Cream	TROLAMINE SALICYLATE	Allure Labs	b6b3102a-4154-2da2-e053-2995a90ae99f	2024-12-05	Warnings	Exact identifier application number: M017
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas DEEP Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu America, Inc.	a4ddb2b9-d023-4c8c-9285-93d51f93207d	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	2024-12-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief - Overnight	LIDOCAINE	Telebrands Corp	1030d478-6805-6579-e063-6294a90a0c76	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Cold Sore Treatment	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	106c0bb2-f2e2-4255-867d-d09ff6a5a2e6	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	82edaef0-0709-4ae1-a664-c9c5adb91ee1	2024-12-02	Warnings	Exact identifier application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On	THERMACARE CAPSAICIN ROLL ON	Clarion Brands LLC	2850f7e7-41dd-f5f9-e063-6394a90ae519	2024-12-02	Warnings	Exact identifier application number: M017
BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	2ec1cf79-c341-4b79-9047-ce29f0dff419	2024-11-29	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	242204d3-efc7-f7a9-e063-6294a90a5af1	2024-11-27	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76348-720-01	76348072001	1 TUBE in 1 BOX (76348-720-01) / 118 mL in 1 TUBE (76348-720-04)	1 tube	2022-01-03	0000-00-00	No	No	Current
76348-720-04	76348072004	118 mL in 1 TUBE	118 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DermaRad Relief Topical Rehydrating Emulsion	RENU LABORATORIES, LLC	2025-05-06	HUMAN OTC DRUG LABEL	7