DermaCen Protectant

Product NDC
62654-313
11-digit product format
626540313
Labeler code
62654
Product ID
62654-313_283710c4-f9f7-4f91-898e-a538eb3c08be
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Central Solutions Inc
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2001-01-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
5 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct62654-313DDiscontinued by firm2026-10-05
excluded packagepackage62654-31362654-313-06DDiscontinued 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 · 42 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 packagepackage62654-313-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62654-313-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62654-313-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62654-313-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62654-313-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62654-313-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62654-313-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62654-313-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62654-313-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62654-313-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62654-313-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62654-313-06557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62654-313-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62654-313-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62654-313-061332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62654-313-06fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62654-313-0686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62654-313-06bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62654-313-068dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62654-313-06e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62654-313-069bebd1f3094a…5416666fcb17…

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
62654-313-062020-01-31C16284748780-19d75b9d0-153d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
CORN OILINACTIVE INGREDIENT8470G57WFMDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01QDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
QUADROSILANINACTIVE INGREDIENTC5KT601WPMDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VDERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62654-313DERMACEN PROTECTANT (ZINC OXIDE) CREAM [CENTRAL SOLUTIONS INC]2Legacy NDC20181207_64cb72ba-fa90-4f5f-a962-643009cd2aac.zip