Secura Two Step Kit

Product NDC
50484-344
11-digit product format
504840344
Labeler code
50484
Product ID
50484-344_0cb1b4ad-56c4-4228-a8f2-532d5e6105ea
Type
HUMAN OTC DRUG
Nonproprietary name
BENZETHONIUM CHLORIDE AND ZINC OXIDE
Dosage form
KIT
Route
TOPICAL
Labeler
Smith & Nephew, Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-08-01
Marketing end
2020-01-31
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct50484-344DDiscontinued by firm2026-09-14
excluded packagepackage50484-34450484-344-00DDiscontinued by firm2026-09-14

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 packagepackage50484-344-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50484-344-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50484-344-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50484-344-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50484-344-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50484-344-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50484-344-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50484-344-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50484-344-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50484-344-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50484-344-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50484-344-00557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50484-344-00EA - Each50484-344565c5b6b-36b2-457d-a8a3-23de7b452e1312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
BENZETHONIUMACTIVE MOIETY1VU15B70BPSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ZINCACTIVE MOIETYJ41CSQ7QDSSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ALLANTOININACTIVE INGREDIENT344S277G0ZSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ALOE VERA FLOWERINACTIVE INGREDIENT575DY8C1ERSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
CLOVE OILINACTIVE INGREDIENT578389D6D0SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RSECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]7