Antiseptic Oral Rinse
Cetylpyridinium Chloride
Sage Products Llc
Human Otc Drug
NDC 53462-175Antiseptic Oral Rinse also known as Cetylpyridinium Chloride is a human otc drug labeled by 'Sage Products Llc'. National Drug Code (NDC) number for Antiseptic Oral Rinse is 53462-175. This drug is available in dosage form of Mouthwash. The names of the active, medicinal ingredients in Antiseptic Oral Rinse drug includes Cetylpyridinium Chloride - .5 mg/mL . The currest status of Antiseptic Oral Rinse drug is Active.
Drug Information:
| Drug NDC: | 53462-175 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Antiseptic Oral Rinse |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Cetylpyridinium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sage Products Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Mouthwash |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CETYLPYRIDINIUM CHLORIDE - .5 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | BUCCAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 21 Jun, 2000 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sage Products LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1251617
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | D9OM4SK49P
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53462-175-60 | 7 mL in 1 PACKET (53462-175-60) | 28 Dec, 2001 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antiseptic rinse
Product Elements:
Antiseptic oral rinse cetylpyridinium chloride water sorbitol peppermint potassium sorbate polysorbate 80 polysorbate 20 citric acid monohydrate fd&c blue no. 1 cetylpyridinium chloride cetylpyridinium
Indications and Usage:
Use helps reduce chance of infection in minor oral irritation.
Warnings:
Warnings stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days. swelling, rash or fever develops. irritation, pain or redness persists or worsens. keep out of reach of children. if more than used for antisepsis is accidentally swallowed, get medical help or contact a poison control center right away.
Dosage and 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.
Stop Use:
Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days. swelling, rash or fever develops. irritation, pain or redness persists or worsens.
Package Label Principal Display Panel:
Antiseptic oral rinse aor packet
Further Questions:
Questions? call toll free 800-323-2220