FDA.reportPublic FDA data

Coralite Muscle and Joint Pain Relief

Product NDC
65923-161
11-digit product format
659230161
Labeler code
65923
Product ID
65923-161_41b3eea0-2c62-fac8-e063-6394a90aad4e
Type
HUMAN OTC DRUG
Nonproprietary name
Capsacin
Dosage form
LIQUID
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-08
Substance
CAPSAICIN
Active strength
.0015 g/mL
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 Muscle and Joint Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.0015 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
792051Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba9a3d72-db7a-4dd0-9220-f43c9ed87114Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-161-40Coralite Muscle and Joint Pain Relief40 mL in 1 BOTTLE, WITH APPLICATORLIQUID409
65923-161-40Coralite Muscle and Joint Pain Relief1 in 1 BOXLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMCORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMCORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ECORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RCORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-161CORALITE MUSCLE AND JOINT PAIN RELIEF (CAPSACIN) LIQUID [UNITED EXCHANGE CORP.]8Current NDC, Legacy NDC, 2 package rows20250112_ba9a3d72-db7a-4dd0-9220-f43c9ed87114.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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact identifier
application number: M017
PURE EASE Neur Cream Instant Deep Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.e46a4636-6405-440a-a05a-862c354bab542023-11-13WarningsExact identifier
application number: M017
Cryomax CoolingMENTHOLLIFE WEAR TECHNOLOGIES0a0ae5ba-9fac-45f6-e063-6294a90ad5552023-11-13WarningsExact identifier
application number: M017
LBri Super Aloe Stop The PainMETHYL SALICYLATE, MENTHOL, CAPSAICINL'Bris, Pure 'N Natural8fb2010c-c34b-4552-858d-a0188ad313ad2023-11-11WarningsExact identifier
application number: M017
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
application number: M017
Human Science Muscle Pain ReliefMETHYL SALICYLATE, MENTHOLHuman Science, LLC4bccc017-264b-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
application number: M017
GOLD ICE Pain ReliefMENTHOLEden's Answers, Inc.a1356c39-42b9-4bd8-a873-bcd40717058b2023-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
792051capsaicin 0.15 % Topical SolutionPSNba9a3d72-db7a-4dd0-9220-f43c9ed871149
792051capsaicin 1.5 MG/ML Topical SolutionSCDba9a3d72-db7a-4dd0-9220-f43c9ed871149
792051capsaicin 0.15 % Topical SolutionSYba9a3d72-db7a-4dd0-9220-f43c9ed871149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65923-161-40659230161401 BOTTLE, WITH APPLICATOR in 1 BOX (65923-161-40) / 40 mL in 1 BOTTLE, WITH APPLICATOR2015-08-110000-00-00NoNoCurrent