Is Smith & Nephew, Inc. FDA approved?

Smith & Nephew, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Smith & Nephew, Inc.'s drugs manufactured?

The FDA register lists Fort Worth, TX. Registered operations: analytical testing, finished drug manufacture.

What drugs does Smith & Nephew, Inc. make?

14 products are listed under Smith & Nephew, Inc. in the openFDA NDC Directory, most often as cream; ointment; spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Smith & Nephew, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 14
Labeller names: 4
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Smith & Nephew Wound ManagementRegistrant: Smith & Nephew, Inc.	4900 W Vickery Blvd, Fort Worth, Texas (TX) 76107, United States (USA)	Analytical testing, Finished drug manufacture	3011034132125458849

Catalogue

Drug listings by form and route

14 active NDC listings: 13 human otc drug, 1 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 13, BLA 1.

Dosage form	NDCs
cream	7
ointment	3
spray	3
cloth	1

Route	NDCs
topical	14

Labeller name on the listing	NDCs
smith & nephew medical ltd	10
smith & nephew medical ltd.	2
smith & nephew, inc	1
smith & nephew, medical ltd	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
COLLAGENASE SANTYL	COLLAGENASE SANTYL	ointment, topical	50484-010BLA
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	spray, topical	69740-490OTC MONOGRAPH DRUG
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	spray, topical	69740-492OTC MONOGRAPH DRUG
I.V. Prep Antiseptic Wipe	ISOPROPYL ALCOHOL	cloth, topical	69740-212OTC MONOGRAPH DRUG
Secura Antifungal Extra Thick	MICONAZOLE NITRATE	cream, topical	69740-329OTC MONOGRAPH DRUG
Secura Antifungal Greaseless	MICONAZOLE NITRATE	cream, topical	69740-328OTC MONOGRAPH DRUG
Secura Dimethicone Protectant	DIMETHICONE	cream, topical	69740-322OTC MONOGRAPH DRUG
Secura Extra Protective	ZINC OXIDE	cream, topical	69740-324OTC MONOGRAPH DRUG
Secura Extra Protective Cream	ZINC OXIDE	cream, topical	69740-325OTC MONOGRAPH DRUG
Secura Moisturizing Cleanser	BENZETHONIUM CHLORIDE	spray, topical	69740-309OTC MONOGRAPH DRUG
Secura Protective	ZINC OXIDE	cream, topical	69740-311OTC MONOGRAPH DRUG
Secura Protective	ZINC OXIDE	cream, topical	69740-312OTC MONOGRAPH DRUG
Secura Protective	petrolatum	ointment, topical	69740-315OTC MONOGRAPH DRUG
Secura Protective	petrolatum	ointment, topical	69740-316OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Sotera Health LLCFort Worth, TX
Pharma Packaging Solutions, LLC dba Tjoapack, LLCFort Worth, TX
Prime Enterprises, LLC dba Prime Matter LabsFort Worth, TX
Alcon Laboratories, IncFort Worth, TX
MasVida Health Care Solutions, LLCFort Worth, TX
Cook Children's Home HealthFort Worth, TX
Eosera IncFort Worth, TX
SOVEREIGN PHARMACEUTICALS, LLCFort Worth, TX

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Enquiry

Common questions

Is Smith & Nephew, Inc. FDA approved?: Smith & Nephew, Inc. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Smith & Nephew, Inc.'s drugs manufactured?: The FDA register lists Fort Worth, TX. Registered operations: analytical testing, finished drug manufacture.
What drugs does Smith & Nephew, Inc. make?: 14 products are listed under Smith & Nephew, Inc. in the openFDA NDC Directory, most often as cream; ointment; spray. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.