FDA.reportPublic FDA data

SINSINPAS Pain Relieving Patch

Product NDC
55264-101
11-digit product format
552640101
Labeler code
55264
Product ID
55264-101_7aa36833-2ba0-70b3-e053-2991aa0a939e
Type
HUMAN OTC DRUG
Nonproprietary name
DL-Camphor, L-menthol, methyl salicylate
Dosage form
PATCH
Route
TOPICAL
Labeler
Sinsin Pharmaceutical Co., Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE
Active strength
6 g/459.93g; g/459.93g; g/459.93g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55264-101IInactivated by FDA2026-08-11
excluded productproduct55264-101DDiscontinued by firm2026-08-11
excluded packagepackage55264-10155264-101-03IInactivated by FDA2026-08-11
excluded packagepackage55264-10155264-101-03DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55264-101-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55264-101-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55264-101-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55264-101-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55264-101-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55264-101-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55264-101-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55264-101-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55264-101-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55264-101-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55264-101-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55264-101-03557ba5c1ecfa…9c80585c8c6e…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-101-01SINSINPAS Pain Relieving Patch459.93 g in 1 PATCHPATCH459.9313
55264-101-02SINSINPAS Pain Relieving Patch20 in 1 POUCHPATCH2013
55264-101-03SINSINPAS Pain Relieving Patch2 in 1 PACKAGEPATCH213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-101SINSINPAS PAIN RELIEVING PATCH (DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]13Legacy NDC, 3 package rows20240106_7aa373e7-1f19-2b5c-e053-2991aa0a0d9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102942camphor 1.21 % / L-menthol 5.54 % / methyl salicylate 6.11 % Medicated PatchPSN7aa373e7-1f19-2b5c-e053-2991aa0a0d9e13
2102942camphor 5560 MG / levomenthol 2550 MG / methyl salicylate 28100 MG Medicated PatchSCD7aa373e7-1f19-2b5c-e053-2991aa0a0d9e13
2102942camphor 1.21 % / L-menthol 5.54 % / methyl salicylate 6.11 % Medicated PatchSY7aa373e7-1f19-2b5c-e053-2991aa0a0d9e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55264-101-0155264010101459.93 g in 1 PATCH459.93 gHistorical
55264-101-025526401010220 in 1 POUCHHistorical
55264-101-03552640101032 POUCH in 1 PACKAGE (55264-101-03) > 20 PATCH in 1 POUCH (55264-101-02) > 459.93 g in 1 PATCH (55264-101-01) 2 pouch2017-05-010000-00-00NoNoCurrent