FDA.reportPublic FDA data

DermaRad Relief Post Radiation Calming

Product NDC
76348-970
Requested package NDC
76348-970-01
11-digit product format
763480970
Labeler code
76348
Product ID
76348-970_3492e688-b7e8-d380-e063-6294a90a329f
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
2022-08-08
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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
DermaRad Relief Post Radiation Calming
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE1.5 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2607527Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5d64929-fb9c-7ebc-e053-2995a90a9318Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-970-012025-05-09C16284748780-12cef2736-b5d7-d83d-e063-dadaa90ab31fDermaRad Relief Post Radiation Calming Serum with 3% Lidocaine
76348-970-012025-01-30C16284748780-12cef2736-b5d7-d83d-e063-dadaa90ab31fDermaRad Relief Post Radiation Calming Serum with 3% Lidocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-970-01DermaRad Relief Post Radiation Calming1 in 1 BOXLIQUID12
76348-970-50DermaRad Relief Post Radiation Calming50 mL in 1 BOTTLE, PUMPLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-970DERMARAD RELIEF POST RADIATION CALMING (LIDOCAINE 3 PERCENT) LIQUID [RENU LABORATORIES, LLC]2Current NDC, Legacy NDC, 2 package rows20250511_e5d64929-fb9c-7ebc-e053-2995a90a9318.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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2607527lidocaine 3 % Topical SolutionPSNe5d64929-fb9c-7ebc-e053-2995a90a93182
2607527lidocaine 30 MG/ML Topical SolutionSCDe5d64929-fb9c-7ebc-e053-2995a90a93182
2607527lidocaine 3 % Topical SolutionSYe5d64929-fb9c-7ebc-e053-2995a90a93182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76348-970-01763480970011 BOTTLE, PUMP in 1 BOX (76348-970-01) / 50 mL in 1 BOTTLE, PUMP (76348-970-50) 2022-08-080000-00-00NoNoCurrent