DERMAPROT

Product NDC
66854-004
11-digit product format
668540004
Labeler code
66854
Product ID
66854-004_232823a8-d199-498c-98b3-15e8ad88ee2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRICLOSAN
Dosage form
LIQUID
Route
TOPICAL
Labeler
SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Application
part333E
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-08-30
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
0 mg/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct66854-004IInactivated by FDA2026-10-12
excluded packagepackage66854-00466854-004-01IInactivated by FDA2026-10-12

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 · 44 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 packagepackage66854-004-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66854-004-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66854-004-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66854-004-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66854-004-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66854-004-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66854-004-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66854-004-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66854-004-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66854-004-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66854-004-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66854-004-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66854-004-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66854-004-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66854-004-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66854-004-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66854-004-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66854-004-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66854-004-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66854-004-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66854-004-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66854-004-01110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66854-004-012019-11-13C16284748780-197449f38-c902-f6ea-e053-dbdaa90aa703DERMAPROT TRICLOTREX-B

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66854-004-01DERMAPROTTRICLOTREX-B500 mL in 1 BOTTLELIQUID5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
TRICLOSANACTIVE MOIETY4NM5039Y5XDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
DIPYRITHIONEINACTIVE INGREDIENT9L87N86R9ADERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHKDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66854-004DERMAPROT TRICLOTREX-B (TRICLOSAN) LIQUID [SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1Legacy NDC, 1 package rows20120830_33ff7919-c967-4874-8d16-30afbdfb9352.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66854-004-0166854000401500 mL in 1 BOTTLE500 mlHistorical