FDA.reportPublic FDA data

Leader Medicated Relief Patch

Product NDC
70000-0206
Requested package NDC
70000-0206-2
11-digit product format
700000206
Labeler code
70000
Product ID
70000-0206_d4efd80c-ce47-4b6f-e053-2a95a90a27d8
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC) LEVOMENTHOL SALICYLIC ACID
Dosage form
PATCH
Route
TOPICAL
Labeler
CARDINAL HEALTH, INC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Active strength
1 1/1; 1/1; 1/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-020670000-0206-2DDiscontinued 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 · 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, Related label table
NDCEffectiveRelated label
70000-0206-12025-12-23LEADER Relief Patch No-Mess Topical Analgesic
70000-0206-22025-12-23LEADER Relief Patch No-Mess Topical Analgesic
70000-0206-12024-01-30LEADER Relief Patch No-Mess Topical Analgesic
70000-0206-22024-01-30LEADER Relief Patch No-Mess Topical Analgesic

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0206LEADER MEDICATED RELIEF PATCH (CAMPHOR (SYNTHETIC) LEVOMENTHOL SALICYLIC ACID) PATCH [CARDINAL HEALTH, INC]3Legacy NDC20220107_80f68cdf-9601-495f-a7cb-fd9bdb35fde6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0206-27000002060240 POUCH in 1 BOX (70000-0206-2) > 1 PATCH in 1 POUCH40 pouch2016-12-010000-00-00NoNoCurrent