Is Melaleuca, Inc. FDA approved?

Melaleuca, 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 Melaleuca, Inc.'s drugs manufactured?

The FDA register lists Idaho Falls, ID; Knoxville, TN. Registered operations: finished drug manufacture.

What drugs does Melaleuca, Inc. make?

53 products are listed under Melaleuca, Inc. in the openFDA NDC Directory, most often as lotion; cream; stick. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Melaleuca, Inc.

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

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Registered sites: 2
Active NDC listings: 53
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MelaleucaRegistrant: Melaleuca, Inc.	735 W 25th Street, Idaho Falls, Idaho (ID) 83402, United States (USA)	Finished drug manufacture	3021937079711683
Melaleuca, Inc.	5301 National Drive, Knoxville, Tennessee (TN) 37914, United States (USA)	Finished drug manufacture	1000151121805617610

Catalogue

Drug listings by form and route

53 active NDC listings: 53 human otc drug. By marketing category: OTC MONOGRAPH DRUG 49, ANDA 2, OTC MONOGRAPH NOT FINAL 2.

Dosage form	NDCs
lotion	18
cream	9
stick	8
paste, dentifrice	4
lozenge	2
tablet	2
tablet, coated	2
cloth	1
gel	1
liquid	1
ointment	1
paste	1
soap	1
spray	1
tablet, film coated	1

Route	NDCs
topical	46
oral	7

Labeller name on the listing	NDCs
melaleuca inc.	26
melaleuca, inc.	22
melaleuca, inc	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Affinia Antiperspirant Deodorant Sweet Cream and Willow	Aluminum zirconium tetrachlorohydrex gly	stick, topical	54473-307OTC MONOGRAPH DRUG
Affinia Antiperspirant Deodorant Vanilla Musk and Jasmine	Aluminum Zirconium Trichlorohydrex Gly	stick, topical	54473-338OTC MONOGRAPH DRUG
Alloy Antiperspirant and Deodorant	Aluminum Zirconium Trichlorohydrex Gly	stick, topical	54473-339OTC MONOGRAPH DRUG
Alloy Antiperspirant and Deodorant	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY	stick, topical	54473-405OTC MONOGRAPH DRUG
Calmicid AC Acid Reducer	Famotidine	tablet, coated, oral	54473-411OTC MONOGRAPH DRUG
Clarity Clear Skin Solutions Acne Spot Treatment	Benzoyl Peroxide	cream, topical	54473-402OTC MONOGRAPH DRUG
Clear Defense	Ethyl alcohol	gel, topical	54473-311OTC MONOGRAPH DRUG
Clear Defense	Hand Sanitizing Wipes	cloth, topical	54473-409OTC MONOGRAPH DRUG
CounterAct Allergy	Loratadine	tablet, oral	54473-166ANDA
CounterAct Cough Drops Honey Lemon	Menthol	lozenge, oral	54473-132OTC MONOGRAPH DRUG
CounterAct Cough Drops Orchard Cherry	Menthol	lozenge, oral	54473-297OTC MONOGRAPH DRUG
CounterAct IB	Ibuprofen	tablet, coated, oral	54473-306ANDA
CounterAct PM	Acetaminophen and Diphenhydramine	tablet, oral	54473-304OTC MONOGRAPH NOT FINAL
CounterAct Pain	Acetaminophen	tablet, film coated, oral	54473-305OTC MONOGRAPH DRUG
DermaCort Anti-itch	Hydrocortisone	cream, topical	54473-117OTC MONOGRAPH DRUG
Dermatin Antifungal	Clotrimazole	cream, topical	54473-096OTC MONOGRAPH DRUG
Exceed Total Care Sensitive Peppermint Tooth Polish	Potassium Nitrate and Sodium Fluoride	paste, dentifrice, topical	54473-340OTC MONOGRAPH DRUG
Exceed Total Care Sensitive Spearmint Tooth Polish	Potassium Nitrate and Sodium Fluoride	paste, dentifrice, topical	54473-337OTC MONOGRAPH DRUG
HemAway	Lidocaine	cream, topical	54473-336OTC MONOGRAPH DRUG
Koala Kubs Diaper Rash Cream	Diaper Rash Cream	cream, topical	54473-333OTC MONOGRAPH DRUG
Koala Pals Berrylicious	Sodium Fluoride	paste, dentifrice, topical	54473-300OTC MONOGRAPH DRUG
Original Pain-A-Trate Pain-Relieving Cream	Camphor and Menthol and Methyl Salicylate	cream, topical	54473-335OTC MONOGRAPH DRUG
Renew Intensive Skin Therapy Targeted Eczema Treatment	Colloidal Oatmeal	cream, topical	54473-410OTC MONOGRAPH DRUG
Sei Bella CC Brightening Creme Fair	Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%	lotion, topical	54473-279OTC MONOGRAPH DRUG
Sei Bella CC Brightening Creme Light	Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%	lotion, topical	54473-280OTC MONOGRAPH DRUG
Sei Bella CC Brightening Creme Medium	Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%	lotion, topical	54473-281OTC MONOGRAPH DRUG
Sei Bella CC Brightening Creme Medium Tan	Octinoxate 7.5%, Titanium Dioxide 5%, Zinc Oxide 1%	lotion, topical	54473-282OTC MONOGRAPH DRUG
Sei Bella Clarity Clear Acne All-Over Clearing Serum Cleansing Serum	Salicylic Acid	soap, topical	54473-400OTC MONOGRAPH DRUG
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatment	Salicylic Acid	liquid, topical	54473-401OTC MONOGRAPH DRUG
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen	Sunscreen	cream, topical	54473-403OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Cream	115 N	lotion, topical	54473-406OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Cream	230 N	lotion, topical	54473-407OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Cream	410 N	lotion, topical	54473-408OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Deep 550 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-290OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-283OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-284OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Medium 300 W	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-285OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Medium 320 C	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-286OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Medium 440 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-287OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-288OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-289OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-310OTC MONOGRAPH DRUG
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N	Titanium Dioxide 5% and Zinc Oxide 5%	lotion, topical	54473-309OTC MONOGRAPH DRUG
Sensitive Tooth Polish	Potassium Nitrate and Sodium Fluoride	paste, dentifrice, topical	54473-302OTC MONOGRAPH NOT FINAL
Sun Shades Lip Balm Cranberry Tangerine	Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%	stick, topical	54473-223OTC MONOGRAPH DRUG
Sun Shades Lip Balm Mountain Mint	Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%	stick, topical	54473-220OTC MONOGRAPH DRUG
Sun Shades Lip Balm Pina Colada	Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%	stick, topical	54473-226OTC MONOGRAPH DRUG
Sun Shades Lip Balm Vanilla Bean	Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%	stick, topical	54473-219OTC MONOGRAPH DRUG
Sun Shades Mineral Plus Sunscreen with Zinc Oxide	OCTISALATE 5%, OCTOCRYlENE 3%, ZINC OXIDE 10.5%	lotion, topical	54473-218OTC MONOGRAPH DRUG
Sun Shades Sunscreen Sunscreen SPF 50	avobenzone, homosalate, octisalate, octocrylene	spray, topical	54473-404OTC MONOGRAPH DRUG
Triple Antibiotic	Bacitracin zinc and Neomycin and Polymyxin B sulfate	ointment, topical	54473-291OTC MONOGRAPH DRUG
Ultra Pain-A-Trate Pain-Relieving Cream	Camphor and Menthol and Methyl Salicylate	cream, topical	54473-334OTC MONOGRAPH DRUG
Whitening Tooth Polish	Sodium Fluoride	paste, topical	54473-301OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

PETNET Solutions, Inc.KNOXVILLE, TN · 2 sites
Fresenius Medical Care Renal Therapies Group, LLCKnoxville, TN · 2 sites
Ionetix CorporationKnoxville, TN
Craig SmithKnoxville, TN
Holston Gases, Inc.Knoxville, TN
FOCUS Scientific ServicesKnoxville, TN
DOC BrandsKnoxville, TN
Radnostix, Inc.Idaho Falls, ID

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Enquiry

Common questions

Is Melaleuca, Inc. FDA approved?: Melaleuca, 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 Melaleuca, Inc.'s drugs manufactured?: The FDA register lists Idaho Falls, ID; Knoxville, TN. Registered operations: finished drug manufacture.
What drugs does Melaleuca, Inc. make?: 53 products are listed under Melaleuca, Inc. in the openFDA NDC Directory, most often as lotion; cream; stick. 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.