Secura Protective

Product NDC: 50484-312
11-digit product format: 504840312
Labeler code: 50484
Product ID: 50484-312_a4ebdf39-83e5-4f3a-89b8-ad2dcaa342f6
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Smith & Nephew, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2003-08-01
Marketing end: 2020-07-31
Substance: ZINC OXIDE
Active strength: 100 mg/g
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50484-312		D	Discontinued by firm		2026-10-05
excluded package	package	50484-312	50484-312-00	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50484-312-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50484-312-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50484-312-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50484-312-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50484-312-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50484-312-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50484-312-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50484-312-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50484-312-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50484-312-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50484-312-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50484-312-00	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50484-312-00	GM - Gram	50484-312	8d00460c-4569-4c98-8aa9-7c0928850ea2	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZETHONIUM CHLORIDE	ACTIVE INGREDIENT	PH41D05744	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
BENZETHONIUM	ACTIVE MOIETY	1VU15B70BP	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ZINC	ACTIVE MOIETY	J41CSQ7QDS	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ALOE VERA FLOWER	INACTIVE INGREDIENT	575DY8C1ER	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
CLOVE OIL	INACTIVE INGREDIENT	578389D6D0	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
POLYOXYL 40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	SECURA TWO STEP KIT (BENZETHONIUM CHLORIDE AND ZINC OXIDE CREAM) KIT [SMITH & NEPHEW, INC.]	7
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ZINC	ACTIVE MOIETY	J41CSQ7QDS	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ALOE	INACTIVE INGREDIENT	V5VD430YW9	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ALOE VERA FLOWER	INACTIVE INGREDIENT	575DY8C1ER	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
CLOVE OIL	INACTIVE INGREDIENT	578389D6D0	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
POLYOXYL 40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW, INC.]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Secura Two Step Kit	Smith & Nephew, Inc. \| Swiss-American CDMO, LLC \| ENCUBE ETHICALS PVT LTD	2016-07-22	HUMAN OTC DRUG LABEL	8
Secura Protective Cream	Smith & Nephew, Inc. \| ENCUBE ETHICALS PVT LTD	2016-05-03	HUMAN OTC DRUG LABEL	7

Secura Protective

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#