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 107 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief roll-on	LIDOCAINE 4%	Bionpharma Inc.	f607b6dc-8d13-604a-e053-2995a90a59ab	2024-12-23	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE 1%	Trifecta Pharmaceuticals USA LLC	af5daf6c-bcad-8ebf-e053-2a95a90af1b0	2024-12-20	Warnings	Exact identifier application number: M017
Pain Itch Relief	LIDOCAINE HCI	Trifecta Pharmaceutical USA LLC	f40b19a8-795c-f514-e053-2a95a90a6d15	2024-12-20	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Rugby Laboratories	132982ea-cce6-687c-e063-6294a90a4632	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	9bb98452-a605-5c20-e053-2995a90a1ea7	2024-12-20	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Exact identifier application number: M017
Itch Relief Cream	ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%	Pharmacy Value Alliance LLC	37fe6d82-adee-4f58-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Warrior First Aid Anti Itch	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	ec6e9a5b-c61d-a385-e053-2995a90ac936	2024-12-20	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE HCL	Derma Care Research Labs, LLC	ff227154-cf3b-9796-e053-6294a90a5535	2024-12-20	Warnings	Exact identifier application number: M017
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE HCL 4%	Meijer	f31b11ed-2ff9-5cfc-e053-2a95a90af2ca	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier application number: M017
Mirakel Pain and Itch Relief	BENZOCAINE 20%, RESORCINOL 3%	Sanvio, Inc.	ed34d728-0275-e209-e053-2995a90a93ff	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE 4%	Meijer	bed67c31-c479-6f9b-e053-2a95a90a5516	2024-12-20	Warnings	Exact identifier application number: M017
Blue-Emu Ultra with Hemp Seed	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9	2024-12-20	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	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