FDA.reportPublic FDA data

Hot and Cold Medicated Patch

Product NDC
68016-068
11-digit product format
680160068
Labeler code
68016
Product ID
68016-068_ef57135f-5c35-05ff-e053-2995a90afad7
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-10-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-068IInactivated by FDA2026-08-17
excluded packagepackage68016-06868016-068-05IInactivated by FDA2026-08-17

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-068-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-068-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-068-05bd6a592717d7…303034d00443…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-068-059bebd1f3094a…5416666fcb17…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-12-29Hot and Cold Medicated Patch
2022-01-28Hot and Cold Medicated Patch
2020-07-16Hot and Cold Medicated Patch
2020-01-31Hot and Cold Medicated Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-068-05Hot and Cold Medicated Patch9 g in 1 POUCHPATCH96
68016-068-05Hot and Cold Medicated Patch5 in 1 BOXPATCH56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-068HOT AND COLD MEDICATED PATCH (MENTHOL) PATCH [CHAIN DRUG CONSORTIUM, LLC]6Legacy NDC, 2 package rows20241222_1630e996-5243-4fb4-9c91-216fb8e65800.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN1630e996-5243-4fb4-9c91-216fb8e658006
420222menthol 0.05 MG/MG Medicated PatchSCD1630e996-5243-4fb4-9c91-216fb8e658006
420222menthol 5 % Medicated PatchSY1630e996-5243-4fb4-9c91-216fb8e658006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-068-05680160068055 POUCH in 1 BOX (68016-068-05) > 1 PATCH in 1 POUCH5 pouch2017-10-010000-00-00NoNoCurrent