FDA.reportPublic FDA data

DermaRad Relief Post Radiation Calming

Product NDC
76348-970
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76348-970-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76348-970-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76348-970-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-970-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-970-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-970-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-970-01UExcluded 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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC04b1d605-60aa-56f4-e063-6294a90ae7602025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC0f1406fe-3a2f-bf36-e063-6294a90a7e5e2025-11-17WarningsExact identifier
application number: M017
AY BENDITO CBDMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC30a1c6b7-e37e-32c2-e063-6394a90aa3542025-11-17WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000MENTHOL, CAMPHORWorldwide Cosmetics, Inc0816cc8f-8d0b-de27-e063-6294a90a8a9d2025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLCf6538e3e-4663-679c-e053-2995a90a87b52025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLCf65455d7-04a9-6217-e053-2995a90a7c902025-11-17WarningsExact identifier
application number: M017
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact 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 formatDescriptionUnitsMarketing 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
76348-970-507634809705050 mL in 1 BOTTLE, PUMP50 mlHistorical