ORALABX is a private label oral care manufacturer supporting brands, importers, and private label companies entering the United States market. We produce private label and OEM mouthwash, toothpaste, and breath spray under ISO 22716 and GMP-aligned processes, with documentation prepared for the US regulatory pathway — including FDA OTC drug monograph requirements and Drug Facts labeling for fluoride toothpaste and therapeutic rinses, plus MoCRA facility registration and product listing for cosmetic oral care. We support private label programs for Amazon, retail, pharmacy, and e-commerce channels.

As a private label oral care manufacturer for the US market, we support brands launching mouthwash, toothpaste, and breath spray through Amazon, retail, pharmacy, and e-commerce channels. A key distinction we manage is the cosmetic-versus-OTC-drug pathway: fluoride and anticavity products are regulated as OTC drugs under 21 CFR, while non-therapeutic mouthwash and breath spray are cosmetics under MoCRA. We help brands position and document each product correctly from the start.

Whether you are launching a private label line for Amazon or building a retail oral care range, ORALABX provides manufacturing-side coordination, FDA/MoCRA-aware documentation, and scalable production for the US market — from pilot quantities for market testing through large-scale contract manufacturing.