Coralite Cold and Hot

Product NDC
65923-214
11-digit product format
659230214
Labeler code
65923
Product ID
65923-214_41c7473a-cea8-3353-e063-6294a90a5e41
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-26
Substance
MENTHOL
Active strength
210 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 Cold and Hot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL210 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010823Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
064a6149-a0e2-8a73-e063-6394a90a7953Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-214-01Coralite Cold and Hot1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-214CORALITE COLD AND HOT (MENTHOL) PATCH [UNITED EXCHANGE CORP.]2Current NDC, 1 package rows20241228_064a6149-a0e2-8a73-e063-6394a90a7953.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 48 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Arm SleeveCAPSAICINNufabrx LLC472ef560-1ed6-c912-e063-6394a90aaa1c2025-12-30WarningsExact identifier
application number: M017
Nufabrx Shin SleeveCAPSAICINNufabrx LLC4730bf64-ea0c-ca8d-e063-6394a90af5422025-12-30WarningsExact identifier
application number: M017
Nufabrx Ankle SleeveCAPSAICINNufabrx LLC4730d164-9027-fff2-e063-6394a90a42802025-12-30WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLC473098ca-02f1-c287-e063-6394a90a37e12025-12-30WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINELiberty Procurement, In2d381c48-402f-4e46-81b2-41a184139a612025-12-30WarningsExact identifier
application number: M017
Thera Care Pain Relief Menthol PatchsMENTHOLVeridian Healthcare1faa1d4f-b7fb-4f36-aef1-2fedde114b8e2025-12-30WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFAllegiant Health7f715144-f0c8-48fc-a22d-eac85759c66a2025-12-30WarningsExact identifier
application number: M017
ZIKS ARTHRITIS PAIN RELIEFZIKS ARTHRITIS PAIN RELIEFNnodum Pharmaceuticals5dd4fefc-b70a-4850-819c-1cca6f28aa972025-12-29WarningsExact identifier
application number: M017
Ted and Gregs Pain Rub with Resveratrol Topical AnalgesicMETHYL SALICYLATETed and Greg's Inc.c699438d-595d-4711-801b-51e960aa36682025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain Combo PackMENTHOLWISE CONSUMER PRODUCTS CO.47199677-e04c-768b-e063-6294a90a35242025-12-29WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELCVS HEALTHb8b79e8d-9c84-1700-e053-2995a90af5bd2025-12-29WarningsExact identifier
application number: M017
WALGREENS BURNLIDOCAINE HYDROCHLORIDEWALGREENSb61e6d73-4f41-ef50-e053-2a95a90a0fc62025-12-29WarningsExact identifier
application number: M017
CVS cold and HotMENTHOL 16%CVSd1676df9-530f-1664-e053-2995a90a5b642025-12-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCfa956b6a-1712-4f7a-9490-11866dcd17c82025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Nerve Combo PackMENTHOLWise Consumer Products471d815c-1c34-e0f8-e063-6294a90aca782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d3c8d-7b70-e973-e053-2991aa0aaa782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781dfd66-f006-a2d7-e053-2991aa0a170c2025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3df-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M017
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
application number: M017
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010823menthol 7.5 % Medicated PatchPSN064a6149-a0e2-8a73-e063-6394a90a79533
1010823menthol 0.075 MG/MG Medicated PatchSCD064a6149-a0e2-8a73-e063-6394a90a79533
1010823menthol 7.5 % Medicated PatchSY064a6149-a0e2-8a73-e063-6394a90a79533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65923-214-01659230214011 PATCH in 1 POUCH (65923-214-01) 1 patch2023-09-26NoNoCurrent