Is Atlantis Laboratories, Inc. FDA approved?

Atlantis Laboratories, 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 Atlantis Laboratories, Inc.'s drugs manufactured?

The FDA register lists Conroe, TX. Registered operations: finished drug manufacture.

What drugs does Atlantis Laboratories, Inc. make?

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

Atlantis Laboratories, Inc.

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

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Registered sites: 1
Active NDC listings: 18
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Atlantis Laboratories, Inc.	1601 Airport Rd, Conroe, Texas (TX) 77301, United States (USA)	Finished drug manufacture	1000117629194673984

Catalogue

Drug listings by form and route

18 active NDC listings: 18 human otc drug. By marketing category: OTC MONOGRAPH DRUG 17, NDA 1.

Dosage form	NDCs
solution	6
capsule	2
capsule, liquid filled	2
spray	2
tablet	2
tablet, film coated	2
aerosol, foam	1
cream	1

Route	NDCs
oral	9
topical	9

Labeller name on the listing	NDCs
atlantis consumer healthcare, inc.	16
atlantis consumer healthcare inc.	1
atlantis laboratories, inc.	1

Catalogue

Marketed products

Showing 18 of 19.

Brand	Generic name	Form / route	NDC
BETASEPT	Antiseptic Surgical Scrub	solution, topical	67618-200NDA
Betadine	POVIDONE-IODINE	solution, topical	67618-190OTC MONOGRAPH DRUG
Betadine	POVIDONE-IODINE	spray, topical	67618-192OTC MONOGRAPH DRUG
Betadine Foam Cleanser	Benzalkonium Chloride	aerosol, foam, topical	67618-184OTC MONOGRAPH DRUG
Betadine Gargle	POVIDONE-IODINE	solution, oral	67618-181OTC MONOGRAPH DRUG
Betadine Solution	POVIDONE-IODINE	solution, topical	67618-150OTC MONOGRAPH DRUG
Betadine Solution Swabsticks	POVIDONE-IODINE	solution, topical	67618-153OTC MONOGRAPH DRUG
Betadine Surgical Scrub	POVIDONE-IODINE	solution, topical	67618-151OTC MONOGRAPH DRUG
COLACE EXTRA STRENGTH STOOL SOFTNER	Docusate Sodium	capsule, liquid filled, oral	67618-201OTC MONOGRAPH DRUG
Colace	Docusate sodium	capsule, oral	67618-101OTC MONOGRAPH DRUG
Colace	Docusate sodium - sennosides	tablet, film coated, oral	67618-110OTC MONOGRAPH DRUG
Colace	Docusate sodium	capsule, liquid filled, oral	67618-111OTC MONOGRAPH DRUG
Colace Fast-Acting Saline Laxative	Magnesium hydroxide	capsule, oral	67618-102OTC MONOGRAPH DRUG
Maximum Strength Betadine Clear	Benzalkonium Cl and Pramoxine HCl	spray, topical	67618-183OTC MONOGRAPH DRUG
Senokot	standardized senna concentrate	tablet, film coated, oral	67618-120OTC MONOGRAPH DRUG
Senokot	standardized senna concentrate	tablet, oral	67618-300OTC MONOGRAPH DRUG
Senokot-S	standardized senna concentrate and docusate sodium	tablet, oral	67618-310OTC MONOGRAPH DRUG
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue	ZINC OXIDE	cream, topical	58419-011OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Nova Biologicals, Inc.Conroe, TX

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Enquiry

Common questions

Is Atlantis Laboratories, Inc. FDA approved?: Atlantis Laboratories, 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 Atlantis Laboratories, Inc.'s drugs manufactured?: The FDA register lists Conroe, TX. Registered operations: finished drug manufacture.
What drugs does Atlantis Laboratories, Inc. make?: 19 products are listed under Atlantis Laboratories, Inc. in the openFDA NDC Directory, most often as solution; capsule; capsule, liquid filled. 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.