Aseptil Rojo
Phenol
Menper Distributors, Inc.
Human Otc Drug
NDC 53145-004Aseptil Rojo also known as Phenol is a human otc drug labeled by 'Menper Distributors, Inc.'. National Drug Code (NDC) number for Aseptil Rojo is 53145-004. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Aseptil Rojo drug includes Phenol - 1.4 mg/100mL . The currest status of Aseptil Rojo drug is Active.
Drug Information:
| Drug NDC: | 53145-004 |
| 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: | Aseptil Rojo |
| 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: | Phenol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Menper Distributors, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | PHENOL - 1.4 mg/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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 Feb, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 Jun, 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: | Menper Distributors, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0042279132013
|
| UPC stands for Universal Product Code. |
| UNII: | 339NCG44TV
|
| 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 |
|---|
| 53145-004-01 | 1 BOTTLE, SPRAY in 1 CARTON (53145-004-01) / 30 mL in 1 BOTTLE, SPRAY | 21 Feb, 2012 | 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 oral analgesic/anesthetic
Product Elements:
Aseptil rojo phenol phenol phenol citric acid acetate fd&c red no. 40 glycerin saccharin sodium propylene glycol sodium citrate water
Indications and Usage:
Uses for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.
Warnings:
Warnings sore throat warning: sever or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. consult doctor promptly. do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. when using this product do not use more thani directed stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops difficulty in breathing occurse
Dosage and Administration:
Directions apply to the affected area (five sprays) allow to remain in place for at least 15 seconds, then spit out. use every 2 hours or as directed by a doctor or dentist. children under 12 years of age should be supervised in the use of the product. children under 3 years of age: consult a dentist or doctor.
Package Label Principal Display Panel:
Image description
Further Questions:
Questions? call 1-800-560-5223 m-f 9 am to 4 pm eastern