FDA.reportPublic FDA data

Icy Hot Advanced Relief

Product NDC
41167-0805
Requested package NDC
41167-0805-1
11-digit product format
411670805
Labeler code
41167
Product ID
41167-0805_06448d78-4da1-44d6-b327-ea5983e3b548
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Topical Analgesic
Dosage form
PATCH
Route
TOPICAL
Labeler
Chattem, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-12-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
210 mg/1
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 packagepackage41167-080541167-0805-1DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41167-080541167-0805-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41167-080541167-0805-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0805-0EA - Each41167-0805ed59d252-209f-49ec-b881-927fbe90be3112021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1
POLYISOBUTYLENE (1000 MW)INACTIVE INGREDIENT5XB3A63Y52ICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0805ICY HOT ADVANCED RELIEF (MENTHOL TOPICAL ANALGESIC) PATCH [CHATTEM, INC.]7Legacy NDC20241102_1a100d2a-b0b1-47a2-a1df-5cc394a38b84.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0805-1411670805015 PATCH in 1 CARTON (41167-0805-1) 5 patch2013-10-220000-00-00NoNoCurrent