Antiseptic Oral Rinse
Antiseptic Oral Rinse is an FDA drug label for the active ingredient CETYLPYRIDINIUM CHLORIDE manufactured by Sage Products LLC administered by BUCCAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260624.
- Generic name
- CETYLPYRIDINIUM CHLORIDE
- Manufacturer
- Sage Products LLC
- Product type
- HUMAN OTC DRUG
- Route
- BUCCAL
- Dosage form
- N/A
- NDC
- 53462-175
- Application
- M022
- Label effective
- 20260624
About this product
Antiseptic Oral Rinse is an FDA-registered drug product whose active ingredient is CETYLPYRIDINIUM CHLORIDE. It is labelled by Sage Products LLC taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 53462-175, application M022, label effective 20260624. It is one of 14 FDA drug label records sharing the active ingredient CETYLPYRIDINIUM CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing CETYLPYRIDINIUM CHLORIDE are most often described in connection with: helps reduce, chance infection, minor oral. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use Helps reduce chance of infection in minor oral irritation.
Dosage & Administration
Directions Use up to 4 times daily or as directed by a dentist or doctor. Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab. Instruct to expectorate. Children under 12 years of age: supervise use. Children under 3 years of age: consult a dentist or doctor.
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View labelHow products containing CETYLPYRIDINIUM CHLORIDE compare
FDA lists 14 drug label records with CETYLPYRIDINIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | The Procter & Gamble Manufacturing Company | 3 |
| — | — | Colgate-Palmolive Company | 2 |
| — | — | Nice-Pak Products, LLC | 2 |
| — | — | Sage Products LLC | 2 |
| — | — | Gervest USA Inc | 1 |
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0231-2017 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20. | Sage Products LLC | Class II | Terminated | 20161228 |
| D-0229-2017 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. | Sage Products LLC | Class I | Terminated | 20161228 |
| D-0230-2017 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. | Sage Products LLC | Class II | Terminated | 20161228 |
| D-0370-2018 | Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6173 | Sage Products Inc | Class II | Terminated | 20180221 |
| D-0369-2018 | Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml Antiseptic Oral Rinse, 0.7 fl oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6113 UPC (01)00618029820990 | Sage Products Inc | Class II | Terminated | 20180221 |
Frequently asked questions
What is Antiseptic Oral Rinse used for?
Use Helps reduce chance of infection in minor oral irritation.
Who makes Antiseptic Oral Rinse?
Sage Products LLC is the labeler of record for Antiseptic Oral Rinse. 14 FDA label records share the active ingredient CETYLPYRIDINIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Antiseptic Oral Rinse come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Antiseptic Oral Rinse prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing CETYLPYRIDINIUM CHLORIDE?
Yes. 14 FDA drug label records list CETYLPYRIDINIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Antiseptic Oral Rinse been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.