Saliva, Artificial
FDA product code LFD · Unclassified · Dental
50510(k) clearances
1PMA approvals
4recalls
Manufacturers
- Glaxosmithkline Consumer Healthcare (Gskch) 3
- Laclede, Inc. 3
- Kingswood Laboratories, Inc. 3
- Procter & Gamble Co. 3
- Elevate Oral Care 2
- Eusa Pharma (Uk) Limited 2
- Inpharma A.S. 2
- Oral Biotech 1
- Dr. Fresh, Inc. 1
- Lorin Technologies Corporation 1
- Rowpar Pharmaceuticals, Inc. 1
- Invado Pharmaceuticals 1
- Bartor Pharmacal Co., Inc. 1
- Bio-X Healthcare S.A. 1
- Parnell Pharmaceuticals, Inc. 1
- Laboratoires Carilene S.A.S. 1
- Glaxosmithkline Consumer Healthcare, L.P. 1
- Sinclair Pharmaceuticals, Ltd. 1
- Gebauer Company 1
- Fresenius USA, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253778 | Allday Moisturizing RinseLFD · Traditional | Elevate Oral Care | 02/27/2026SE |
| K250390 | CloSYS® Dry Mouth Sensitive Mouth RinseLFD · Traditional | Rowpar Pharmaceuticals, Inc. | 05/19/2025SE |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)LFD · Traditional | Laclede, Inc. | 04/19/2024SE |
| K234015 | Caphosol® Artifical Saliva (32 doses sachet box)LFD · Traditional | Eusa Pharma (Uk) Limited | 03/11/2024SE |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayLFD · Traditional | Gurunanda, LLC | 08/22/2023SE |
| K202689 | Dentilube SprayLFD · Traditional | Oxy2plus, LLC | 09/03/2021SE |
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | The Procter & Gamble Company | 09/02/2020SE |
| K181839 | CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayLFD · Traditional | Oralabs, Inc. | 11/21/2019SE |
| K190144 | MucoPEGLFD · Traditional | Sunbio, Inc. | 11/05/2019SE |
| K181194 | SmartMouth DryMouth Oral RinseLFD · Traditional | Triumph Pharmaceuticals, Inc. | 02/15/2019SE |
| K180680 | Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLFD · Traditional | Laclede, Inc. | 10/11/2018SE |
| K173808 | VoutiaLFD · Traditional | Jeffrey Ward Cash, Dds | 07/27/2018SE |
| K181134 | GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry…LFD · Traditional | Sunstar Americas, Inc. | 07/13/2018SE |
| K173237 | Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral…LFD · Traditional | Syendgen, Inc. | 03/19/2018SE |
| K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesLFD · Traditional | Dr. Harold Katz, LLC (Dba Therabreath | 03/16/2018SE |
| K163029 | Hydris Oral RinseLFD · Traditional | Biopharm Consult, LLC | 06/19/2017SE |
| K163476 | LubricityLFD · Traditional | You First Services, Incorporated | 05/10/2017SE |
| K162167 | Caphosol Artifical Saliva TabletsLFD · Traditional | Eusa Pharma (Uk) Limited | 03/31/2017SE |
| K152201 | MedActive Oral Gel and SprayLFD · Traditional | Medactive Oral Pharmaceuticals, LLC | 12/30/2015SE |
| K152406 | SalivaMAXLFD · Traditional | Forward Science, LLC | 12/23/2015SE |
| K142657 | Xerostom Saliva Substitute GelLFD · Traditional | Bio Cosmetics, S.L. | 09/14/2015SE |
| K150074 | Elevate Moisturizing SprayLFD · Traditional | Elevate Oral Care | 06/19/2015SE |
| K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray…LFD · Traditional | J.C.E.C. Company, Inc. (Doing Business AS… | 05/26/2015SE |
| K122663 | OramoistLFD · Traditional | Quantum, Inc. | 05/30/2013SE |
| K123731 | Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SprayLFD · Special | Glaxosmithkline Consumer Healthcare (Gskch) | 01/04/2013SE |
| K120552 | Air Lift/Xerostom Artificial SalivaLFD · Traditional | Biocosmetics Laboratories | 06/06/2012SE |
| K111250 | Dry Mouth MouthwashLFD · Traditional | Dr. Fresh, Inc. | 04/27/2012SE |
| K103745 | Biotene Moisturizing Mouth Spray for Dry Mouth Symptom ReliefLFD · Traditional | Glaxosmithkline Consumer Healthcare (Gskch) | 07/20/2011SE |
| K110116 | Xeros Dry Mouth PumpLFD · Traditional | Lorin Technologies Corporation | 04/08/2011SE |
| K101346 | GC Oral Moisturizing GelLFD · Traditional | GC America, Inc. | 01/27/2011SE |
| K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashLFD · Traditional | Glaxosmithkline Consumer Healthcare (Gskch) | 09/28/2010SE |
| K093642 | NeutrasalLFD · Special | Invado Pharmaceuticals | 12/11/2009SE |
| K091718 | NeutrasalLFD · Traditional | Bartor Pharmacal Co., Inc. | 09/02/2009SE |
| K091419 | Vicks Powershot Dry Throat & Mouth ReliefLFD · Traditional | The Procter & Gamble Co. | 08/28/2009SE |
| K072306 | Bioxtra Moisturizing GelLFD · Traditional | Bio-X Healthcare S.A. | 11/15/2007SE |
| K071617 | Oral NeutralizerLFD · Traditional | Oral Biotech | 10/19/2007SE |
| K062653 | Mouthkote Oral Moisturizer, Model 50930-098LFD · Traditional | Parnell Pharmaceuticals, Inc. | 10/27/2006SE |
| K061331 | Oral Balance Liquid/ GelLFD · Traditional | Laclede, Inc. | 07/25/2006SE |
| K051812 | Tgo SprayLFD · Traditional | Laboratoires Carilene S.A.S. | 10/21/2005SE |
| K041563 | Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing DiscsLFD · Traditional | Glaxosmithkline Consumer Healthcare, L.P. | 08/27/2004SE |
| K030802 | CaphosolLFD · Traditional | Inpharma A.S. | 11/25/2003SE |
| K024148 | Salinum, OrclairLFD · Traditional | Sinclair Pharmaceuticals, Ltd. | 09/15/2003SE |
| K981693 | Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model…LFD · Traditional | Gebauer Co. | 08/06/2001SE |
| K991938 | Caphosol Artificial SalivaLFD · Traditional | Inpharma A.S. | 08/10/1999SE |
| K874106 | Glandosane (Salivart) Synthetic SalivaLFD · Traditional | Fresenius USA, Inc. | 04/15/1988SE |
| K851026 | Moi-Stir Oral Swabstick(S)LFD · Traditional | Kingswood Laboratories, Inc. | 05/21/1985SE |
| K840807 | Throat Moi-StirLFD · Traditional | Kingswood Laboratories, Inc. | 05/25/1984SE |
| K822971 | Saliva SubstituteLFD · Traditional | Roxane Laboratories, Inc. | 11/16/1982SE |
| K810157 | Moi-StirLFD · Traditional | Kingswood Laboratories, Inc. | 02/10/1981SE |
PMA approvals
- P790016 Salivart · Westport Pharmaceuticals, Inc. · 09/19/1979
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2012-2025 Class II | Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution…Out of specification stability test result for the Caphosol B solution from process validation lots | Recordati Rare Diseases Inc. | 06/11/2025Open, Classified |
| Z-1182-2021 Class II | SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0…The product may be contaminated with Burkholderia cepacia | Sunstar Americas, Inc. | 02/18/2021Terminated |
| Z-0272-2014 Class II | Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5…Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol. | GlaxoSmithKline, LLC. | 10/17/2013Terminated |
| Z-0497-2007 | Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part…Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic… | Gebauer Company | 01/19/2007Terminated |