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 77 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ink Scribd NumbingLIDOCAINE HCLProdigy Media Inc54173858-aff0-43b2-bc7b-c4ecab9bc3e52025-09-17WarningsExact identifier
application number: M017
Inkorporated NumbingLIDOCAINE HCLProdigy Media Inc3017056c-f3c6-4300-8344-bf6e7d32e8702025-09-17WarningsExact identifier
application number: M017
TattooGirl NumbingLIDOCAINE HCLProdigy Media Inc6abe4540-f6c9-412a-83f3-682df77150572025-09-17WarningsExact identifier
application number: M017
Dr Tatty NumbingLIDOCAINE HCLProdigy Media Inc5bb558c1-bf8f-4956-8732-e19720f62f312025-09-17WarningsExact identifier
application number: M017
Burn Ease CoolingLIDOCAINEProStat First Aid LLCec201ca1-efa0-4797-aec3-115647c29abd2025-09-17WarningsExact identifier
application number: M017
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
application number: M017
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
application number: M017
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
application number: M017
Lidocaine-Pain-Relief-PatchLIDOCAINE-PAIN-RELIEF-PATCHHenan Enokon Medical Instrument Co., Ltd.3ecfa867-50f6-d98a-e063-6394a90aefa02025-09-14WarningsExact identifier
application number: M017
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
application number: M017
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
application number: M017
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
application number: M017
Walgreens Medicated Foot PowderMENTHOLDavion, Inc58e1e7f7-6284-411f-9765-0e63eabca0f32025-09-12WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact 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