FDA.reportPublic FDA data

Coralite Pain Relief

Product NDC
65923-564
11-digit product format
659230564
Labeler code
65923
Product ID
65923-564_41b49d77-4471-c6ae-e063-6394a90aaac6
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl Salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-04-12
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
1.2; 5.7; 6.3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Coralite Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)1.2 g/100g
MENTHOL5.7 g/100g
METHYL SALICYLATE6.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853260Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69aec845-3d4c-d226-e053-2991aa0afd12Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-31Coralite Pain Patch 20 ct. 90156
2022-03-31Coralite Small Pain Relief Patch 20 ct. 90156
2022-01-28Coralite Pain Patch 20 ct. 90156
2022-01-28Coralite Small Pain Relief Patch 20 ct. 90156

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-564-20Coralite Pain Relief20 in 1 PACKAGEPATCH2010
65923-564-20Coralite Pain Relief1 g in 1 PATCHPATCH110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-564CORALITE PAIN RELIEF (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [UNITED EXCHANGE CORP.]8Current NDC, Legacy NDC, 2 package rows20250207_69aec845-3d4c-d226-e053-2991aa0afd12.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 64 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.97345ed4-51c3-4221-852c-2cd563f333172025-11-12WarningsExact identifier
application number: M017
ZHENG GU SHUICAMPHOR, MENTHOLGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD17552943-4f11-42d6-ad41-fbc53f2bbd9a2025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
NeuroMed FABENZOCAINESambria Pharmaceuticals, Inc.605fc242-ad31-4aa9-bd86-fba4ddf0d3052025-11-12WarningsExact identifier
application number: M017
CAPZIXCAPSAICINToprail Chp Llc.a4555840-cf8f-45d8-90bb-3581102b58a72025-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchPSN69aec845-3d4c-d226-e053-2991aa0afd1210
853260camphor 0.012 MG/MG / menthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated PatchSCD69aec845-3d4c-d226-e053-2991aa0afd1210
853260camphor 1.2 % / menthol 5.7 % / methyl salicylate 6.3 % Medicated PatchSY69aec845-3d4c-d226-e053-2991aa0afd1210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-564-206592305642020 PATCH in 1 PACKAGE (65923-564-20) / 1 g in 1 PATCH20 patch2018-04-120000-00-00NoNoCurrent