Antiplaque solution
- Product NDC
- 53462-275
- 11-digit product format
- 534620275
- Labeler code
- 53462
- Product ID
- 53462-275_45782ff8-665a-1142-e063-6394a90a1919
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETYLPYRIDINIUM CHLORIDE
- Dosage form
- MOUTHWASH
- Route
- BUCCAL
- Labeler
- Sage Products LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-01-09
- Substance
- CETYLPYRIDINIUM CHLORIDE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Antiplaque solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETYLPYRIDINIUM CHLORIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D9OM4SK49P |
| Rxcui | 1251617 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53462-275-60 | Antiplaque solution | 7 mL in 1 PACKET | MOUTHWASH | 7 | | 13 |
| 53462-275-60 | QCare Oral Cleansing and Suctioning System, Q8 | 7 mL in 1 PACKET | MOUTHWASH | 14 mL | 0.5 mg in 1mL | 11 |
| 53462-275-60 | QCare Oral Cleansing and Suctioning System, Q4 | 7 mL in 1 PACKET | MOUTHWASH | 14 mL | 0.5 mg in 1mL | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| cetylpyridinium chloride | ACTIVE INGREDIENT | D9OM4SK49P | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| CETYLPYRIDINIUM CHLORIDE | ACTIVE INGREDIENT | D9OM4SK49P | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| HYDROGEN PEROXIDE | ACTIVE INGREDIENT | BBX060AN9V | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| cetylpyridinium | ACTIVE MOIETY | CUB7JI0JV3 | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| CETYLPYRIDINIUM | ACTIVE MOIETY | CUB7JI0JV3 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| HYDROGEN PEROXIDE | ACTIVE MOIETY | BBX060AN9V | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| peppermint | INACTIVE INGREDIENT | V95R5KMY2B | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| potassium sorbate | INACTIVE INGREDIENT | 1VPU26JZZ4 | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53462-275 | ANTIPLAQUE SOLUTION (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [SAGE PRODUCTS LLC] | 11 | Current NDC, Legacy NDC, 1 package rows | 20241116_881d4d08-4b45-486a-93af-18c0e00a5b0e.zip |
| 53462-275 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC] | 11 | Current NDC, Legacy NDC | 20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip |
| 53462-275 | QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC] | 7 | Current NDC, Legacy NDC | 20180629_567bf599-4958-91c7-5c01-9c38a0d2da52.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53462-275-60 | 53462027560 | 7 mL in 1 PACKET (53462-275-60) | 7 ml | 2009-01-09 | 0000-00-00 | No | No | Current |