Soundbody medicated patch

Product NDC
67510-0547
11-digit product format
675100547
Labeler code
67510
Product ID
67510-0547_9f07b89a-9c8a-8dd2-e053-2995a90a4213
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl salicylate
Dosage form
PATCH
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Kareway Product, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2002-02-19
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
31 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct67510-0547IInactivated by FDA2026-08-10
excluded packagepackage67510-054767510-0547-6IInactivated by FDA2026-08-10

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0547-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0547-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0547-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0547-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0547-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0547-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0547-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0547-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0547-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0547-62025-01-30C16284748780-12cef2736-780c-d83d-e063-dadaa90ab31fSoundbody Medicated Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0547-6Soundbody medicated patch1 in 1 BOXPATCH12
67510-0547-6Soundbody medicated patch6 in 1 POUCHPATCH62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0547SOUNDBODY MEDICATED PATCH (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [KAREWAY PRODUCT, INC.]2Legacy NDC, 2 package rows20230219_9f07da88-b008-5b3f-e053-2995a90ac7d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN9f07da88-b008-5b3f-e053-2995a90ac7d42
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD9f07da88-b008-5b3f-e053-2995a90ac7d42
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY9f07da88-b008-5b3f-e053-2995a90ac7d42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0547-6675100547061 POUCH in 1 BOX (67510-0547-6) > 6 PATCH in 1 POUCH1 pouch2020-02-190000-00-00NoNoCurrent