Coralite Medicated Heat

Product NDC
65923-123
11-digit product format
659230123
Labeler code
65923
Product ID
65923-123_4278b319-7062-610a-e063-6394a90a2291
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-10
Substance
CAPSAICIN
Active strength
249 mg/1
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 Medicated Heat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN249 mg/1

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
1043399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0b89c7e-80bc-43c4-840c-5fd567f60b21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-123-01Coralite Medicated Heat249 in 1 PATCHPATCH24912
65923-123-01Coralite Medicated Heat1 in 1 POUCHPATCH112
65923-123-02Coralite Medicated Heat2 in 1 POUCHPATCH212
65923-123-02Coralite Medicated Heat249 in 1 PATCHPATCH24912

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-123CORALITE MEDICATED HEAT (CAPSAICIN) PATCH [UNITED EXCHANGE CORP.]10Current NDC, Legacy NDC, 4 package rows20241222_a0b89c7e-80bc-43c4-840c-5fd567f60b21.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 19 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC3f2b1f48-2d78-4985-a046-9f72de5e1a9b2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC10a8face-47da-ebbe-e063-6294a90a42fe2026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot CreamMENTHOLReckitt Benckiser LLC32450cbf-4ed4-402b-a30e-e08a17bba3fb2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLCa227213b-e89f-7144-e053-2a95a90a7e742026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC00bb462a-27d0-6f74-e063-6394a90a90ec2026-05-13WarningsExact identifier
application number: M017
BioFreeze Dry StickMENTHOLReckitt Benckiser LLC26d62cd2-9209-8cca-e063-6394a90a20282026-05-13WarningsExact identifier
application number: M017
Biofreeze Foot Pain Relief SetMENTHOLReckitt Benckiser LLC4a885eef-0364-4655-bccc-7158c76cc5b22026-05-13WarningsExact identifier
application number: M017
Biofreeze Colorless Roll-OnMENTHOLReckitt Benckiser LLCa8d59d45-0e85-43d1-affd-bbe922c4acb12026-05-13WarningsExact identifier
application number: M017
Biofreeze ColorlessMENTHOLReckitt Benckiser LLC939dbbc3-71ec-4990-840e-7c9b8d4305622026-05-13WarningsExact identifier
application number: M017
Biofreeze Flexible Relief StripMENTHOLReckitt Benckiser LLC6ec26bae-e395-49aa-969e-8c653d6f0b272026-05-13WarningsExact identifier
application number: M017
Biofreeze Day and OvernightMENTHOLReckitt Benckiser LLCfb5c8f89-a720-ad32-e053-6294a90a2abe2026-05-13WarningsExact identifier
application number: M017
Biofreeze FoamMENTHOLReckitt Benckiser LLC890191e8-99ad-489c-8f21-2592f3d319362026-05-13WarningsExact identifier
application number: M017
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP51b7753b-8619-6ea9-e063-6294a90a4ea42026-05-13WarningsExact identifier
application number: M017
DERMFREE Anti-itch CreamHYDROCORTISONE1% ANTI-ITCH CREAMJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c319a-9c43-0e63-e063-6394a90ab8692026-05-13WarningsExact identifier
application number: M017
Valtrum TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELaboratorios Quantium LLCf3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e2026-05-13WarningsExact identifier
application number: M017
Biofreeze Professional ColorlessMENTHOL, UNSPECIFIED FORMReckitt Benckiser4639201c-a67a-475f-8df6-3dc6225803ad2026-05-12WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCbae9946a-4c68-4759-9fb3-0a61a7ad0eb72026-05-12WarningsExact identifier
application number: M017
Instaflex Pain Relief CreamMENTHOLHealthy Directions, LLC665b847a-9cfb-49fc-975b-81c97f9365752026-05-12WarningsExact identifier
application number: M017
Theracare Cold Therapy Pain ReliefMENTHOLVeridian Healthcare51a5a043-07b6-1c96-e063-6394a90aa9262026-05-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNa0b89c7e-80bc-43c4-840c-5fd567f60b2112
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDa0b89c7e-80bc-43c4-840c-5fd567f60b2112
1043399capsaicin 0.025 % Medicated PatchSYa0b89c7e-80bc-43c4-840c-5fd567f60b2112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-123-01659230123011 PATCH in 1 POUCH (65923-123-01) / 249 PATCH in 1 PATCH1 patch2018-10-300000-00-00NoNoCurrent
65923-123-02659230123022 PATCH in 1 POUCH (65923-123-02) / 249 PATCH in 1 PATCH2 patch2016-02-100000-00-00NoNoCurrent