Is Xttrium Laboratories, Inc. FDA approved?

Xttrium Laboratories, Inc. holds 2 FDA-registered establishments 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.

What drugs does Xttrium Laboratories, Inc. make?

37 products are listed under Xttrium Laboratories, Inc. in the openFDA NDC Directory, most often as solution; liquid; rinse. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Xttrium Laboratories, Inc.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 37
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Active ingredient (API) manufacture2Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Xttrium Laboratories, Inc.	436 Park Avenue, Lake Villa, Illinois (IL) 60046, United States (USA)	Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3017764383118572946
Xttrium Laboratories, Inc.	1200 E. Business Center Drive, Mount Prospect, Illinois (IL) 60056, United States (USA)	Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3008436464007470579

Catalogue

Drug listings by form and route

37 active NDC listings: 20 human prescription drug, 16 human otc drug, 1 bulk ingredient. By marketing category: ANDA 18, NDA 18, BULK INGREDIENT 1.

Dosage form	NDCs
solution	15
liquid	13
rinse	5
suspension	2
syrup	2

Route	NDCs
topical	20
oral	16
buccal	1

Labeller name on the listing	NDCs
xttrium laboratories, inc.	34
xttrium laboratories, inc	2
xttrium laboratories inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	solution, topical	0116-0407NDA
ANTISEPTIC SKIN CLEANSER	CHLORHEXIDINE GLUCONATE	solution, topical	0116-1061NDA
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	Chlorhexidine Gluconate 0.12% Oral Rinse	liquid, oral	0116-4075ANDA
Acclean Chlorhexidine Gluconate 0.12% Oral Rinse	Chlorhexidine Gluconate 0.12% Oral Rinse	liquid, oral	0116-6720ANDA
Amantadine	Amantadine	solution, oral	0116-4010ANDA
Antiseptic Skin Cleanser	Chlorhexidine Gluconate 4%	liquid, topical	0116-0137NDA
Antiseptic Skin Cleanser	Chlorhexidine Gluconate 4%	liquid, topical	0116-0161NDA
Antiseptic Skin Cleanser	Chlorhexidine Gluconate 4%	liquid, topical	0116-0401NDA
Antiseptic Skin Cleanser	CHLORHEXIDINE GLUCONATE 4%	liquid, topical	0116-0767NDA
Antiseptic Skin Cleanser	Chlorhexidine Gluconate 4%	liquid, topical	0116-3678NDA
BETASEPT	Antiseptic Surgical Scrub	solution, topical	0116-0200NDA
Bactoshield CHG	Chlorhexidine Gluconate 2%	solution, topical	0116-0038NDA
Bactoshield CHG	Chlorhexidine Gluconate 4%	solution, topical	0116-0039NDA
Bactoshield CHG	CHLORHEXIDINE GLUCONATE	solution, topical	0116-1344NDA
Cardinal Health	CHLORHEXIDINE GLUCONATE 4%	liquid, topical	0116-0061NDA
Chlorhexidine Gluconate	Chlorhexidine Gluconate	liquid, oral	0116-0101ANDA
Chlorhexidine Gluconate	Chlorhexidine Gluconate	rinse, oral	0116-0175ANDA
Chlorhexidine Gluconate	Chlorhexidine Gluconate	rinse, oral	0116-0301ANDA
Chlorhexidine Gluconate	Chlorhexidine Gluconate	rinse, oral	0116-2001ANDA
Chlorhexidine Gluconate	Chlorhexidine Gluconate	rinse, oral	0116-6000ANDA
Chlorhexidine Gluconate 0.12% Oral Rinse	CHLORHEXIDINE GLUCONATE	liquid, buccal	0116-0003ANDA
-	Chlorhexidine Gluconate 20% Solution	liquid	0116-0100BULK INGREDIENT
CliniClean	CHLORHEXIDINE GLUCONATE 4%	solution, topical	0116-0901NDA
DYNA-HEX 2	Chlorhexidine Gluconate	liquid, topical	0116-1021NDA
DYNA-HEX 4	Chlorhexidine Gluconate	liquid, topical	0116-1060NDA
Dyna-Hex 2	Chlorhexidine Gluconate 2%	solution, topical	0116-1022NDA
Foster and Thrive	Chlorhexidine Gluconate 4%	solution, topical	0116-1221NDA
LIDOCAINE HYDROCHLORIDE	Lidocaine Hydrochloride	solution, topical	0116-4025ANDA
Lactulose	Lactulose	solution, oral	0116-4005ANDA
Lidocaine hydrochloride	Lidocaine hydrochloride	solution, oral, topical	0116-4027ANDA
Megestrol Acetate	Megestrol Acetate	suspension, oral	0116-4011ANDA
NUPRO Chlorhexidine Gluconate	CHLORHEXIDINE GLUCONATE	rinse, oral	0116-0800ANDA
Nystatin Oral Suspension	NYSTATIN	suspension, oral	0116-4026ANDA
PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	syrup, oral	0116-4023ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide	Promethazine Hydrochloride and Dextromethorphan Hydrobromide	syrup, oral	0116-4024ANDA
Provon Antimicrobial Foam Handwash	Chlorhexidine Gluconate 2%	solution, topical	0116-8500NDA
Valproic Acid	Valproic Acid	solution, oral	0116-4021ANDA

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Enquiry

Common questions

Is Xttrium Laboratories, Inc. FDA approved?: Xttrium Laboratories, Inc. holds 2 FDA-registered establishments 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 Xttrium Laboratories, Inc.'s drugs manufactured?: The FDA register lists Lake Villa, IL; Mount Prospect, IL. Registered operations: active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Xttrium Laboratories, Inc. make?: 37 products are listed under Xttrium Laboratories, Inc. in the openFDA NDC Directory, most often as solution; liquid; rinse. 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.