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 75 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	2eccf23c-fae2-423c-9cae-549bc4194104	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA BACK AND NECK PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	48fd73e7-1443-4ac7-bf7c-d99bf2449f51	2025-10-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Patch	LIDOCAINE 4%	BluePoint Laboratories	3117273d-e006-2726-e063-6294a90a9c33	2025-10-08	Warnings	Exact identifier application number: M017
EQUATE PAIN RELIEVING PATCHES	LIDOCAINE 4%	WALMART, INC	01e1cc0e-e1c9-d274-e063-6294a90a409e	2025-10-08	Warnings	Exact identifier application number: M017
Equate Pain Relief Balm	MENTHOL 11%, CAMPHOR 11% OINTMENT	WALMART, INC	d8ddf835-f008-ce1f-e053-2a95a90aa9b3	2025-10-08	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Menthol Gel	MENTHOL 2%	Veridian Healthcare	9d2ccb02-746c-4cb9-905d-280987778f4d	2025-10-08	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	3a9019b1-8798-1ef9-e063-6394a90a09a4	2025-10-08	Warnings	Exact identifier application number: M017
Coralite Capsaicin Heat Patch 2ct	CAPSAICIN	United Exchange Corp.	4128b1ac-f540-2611-e063-6294a90ac98b	2025-10-08	Warnings	Exact identifier application number: M017
Ombre Men overtime wipes	BENZOCAINE	Sambria Pharmaceuticals, LLC	405f23ca-99c1-4db4-aba1-2fd7f93f55ee	2025-10-07	Warnings	Exact identifier application number: M017
Pain free IV	LIDOCAINE	Sambria Pharmaceuticals, LLC	7aa4cb20-d452-417f-afdb-307df754ed75	2025-10-07	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	b3bdff5e-37fe-442a-a370-7b19799ea781	2025-10-07	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Patch	MENTHOL, METHYL SALICYLATE	Veridian Healthcare	b65932fd-ee9f-4fa2-b842-01e0f54133c9	2025-10-07	Warnings	Exact identifier application number: M017
AREX SINSIN PAS	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	2013ea44-e2ea-4b36-bddb-7f64163284b6	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVING	LIDOCAINE	Sinsin Pharmaceutical Co., Ltd.	82c0a036-8750-5b3d-e053-2a91aa0a1815	2025-10-07	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL	Sinsin Pharmaceutical Co., Ltd.	81baffcb-c08e-4616-e053-2a91aa0aaf15	2025-10-07	Warnings	Exact identifier application number: M017
Arex Sinsin Pas	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	a851854a-5dfe-4bd5-95f6-67c3f13f1187	2025-10-07	Warnings	Exact identifier application number: M017
Sinsinpas Arex Flex Gel Pain Relieving Patch	L-MENTHOL	Sinsin Pharmaceutical Co., Ltd.	1758ef9b-4fac-4066-e063-6394a90a8cc3	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS CORN REMOVER	SALICYLIC ACID	Sinsin Pharmaceutical Co., Ltd.	e2771dfc-ee57-553f-e053-2a95a90af281	2025-10-07	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	05a09ee5-e7a4-4758-8b16-f60b945a7d82	2025-10-06	Warnings	Exact identifier application number: M017
Lidocanna	LIDOCAINE	PHARMACURE LLC	b28ebbb6-1112-4750-a2bb-f96b03fabe6e	2025-10-06	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