Icequake Coldn Hot medicated patch

Product NDC
69822-014
11-digit product format
698220014
Labeler code
69822
Product ID
69822-014_0b57dc81-5724-2787-e063-6394a90a04b0
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
Southern Sales & Service, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-02
Substance
MENTHOL
Active strength
50 mg/g
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
Icequake Coldn Hot medicated patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL50 mg/g

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89202c52-9eb7-4e5a-a709-4a66ab0d3a72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-014-04Icequake Coldn Hot medicated patch4 in 1 POUCHCLOTH44
69822-014-04Icequake Coldn Hot medicated patch9.5 g in 1 PATCHCLOTH9.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-014ICEQUAKE COLDN HOT MEDICATED PATCH (MENTHOL) CLOTH [SOUTHERN SALES & SERVICE, INC.]4Current NDC, Legacy NDC, 2 package rows20231201_89202c52-9eb7-4e5a-a709-4a66ab0d3a72.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 119 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFId1ac686e-62f2-4177-8abc-8c7ca578de1a2024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Ince688967e-799a-4fc8-a19a-f0012b90e76b2024-11-15WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCa0d0e82b-03ff-4d43-9be0-0e414ee499702024-11-15WarningsExact identifier
application number: M017
DG health hydrocortisoneHYDROCORTISONEDolgencorp, LLC40710bae-32bb-47fd-b3dd-31d2c98ee70f2024-11-15WarningsExact identifier
application number: M017
Meijer Ultra Strength Pain Relieving Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEMeijer Distribution, Inc6319b019-8e17-4de1-b4e0-b402288a97d42024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving analgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc9953be94-5768-448f-83de-f5e53a2972cc2024-11-15WarningsExact identifier
application number: M017
careone anti itchHYDROCORTISONEAmerican Sales Company5f7b1435-ebee-4093-847a-79e8d66414042024-11-15WarningsExact identifier
application number: M017
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN89202c52-9eb7-4e5a-a709-4a66ab0d3a724
420222menthol 0.05 MG/MG Medicated PatchSCD89202c52-9eb7-4e5a-a709-4a66ab0d3a724
420222menthol 5 % Medicated PatchSY89202c52-9eb7-4e5a-a709-4a66ab0d3a724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-014-04698220014044 PATCH in 1 POUCH (69822-014-04) / 9.5 g in 1 PATCH4 patch2022-11-020000-00-00NoNoCurrent