FDA.reportPublic FDA data

Cool Breeze

Product NDC
72744-778
Requested package NDC
72744-778-40
11-digit product format
727440778
Labeler code
72744
Product ID
72744-778_d5d918eb-0f7d-415b-a019-cf5535996ac4
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
GEL
Route
TOPICAL
Labeler
Cool Breeze US LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-12-06
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72744-77872744-778-40IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72744-778-402024-01-30C16284748780-11030e365-3d8d-111a-e063-dadaa90a10e2COOL BREEZE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72744-778-40Cool Breeze113 g in 1 TUBEGEL1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72744-778COOL BREEZE (MENTHOL, METHYL SALICYLATE) GEL [COOL BREEZE US LLC]1Legacy NDC, 1 package rows20211209_8ed18295-01ff-4a63-8391-54bbb4be55a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105836menthol 5 % / methyl salicylate 4 % Topical GelPSN8ed18295-01ff-4a63-8391-54bbb4be55a71
2105836menthol 0.05 MG/MG / methyl salicylate 0.04 MG/MG Topical GelSCD8ed18295-01ff-4a63-8391-54bbb4be55a71
2105836menthol 5 % / methyl salicylate 4 % Topical GelSY8ed18295-01ff-4a63-8391-54bbb4be55a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72744-778-4072744077840113 g in 1 TUBE (72744-778-40) 113 g2021-12-060000-00-00NoNoCurrent