Rocainol Topical Analgesic Ointment
NDC 54312-825

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 54312-825?
  4. Rocainol Topical Analgesic Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Rocainol Topical Analgesic (methyl salicylate, menthol) is a OTC MONOGRAPH DRUG-approved product labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a ointment for topical administration. This product entry covers the primary NDC 54312-825 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54312-825
Proprietary Name:
Rocainol Topical Analgesic
Non-Proprietary Name: [1]
Methyl Salicylate, Menthol
Substance Name: [2]
Menthol; Methyl Salicylate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Compania Internacional De Comercio, S.a.p.i De C.v.
Labeler Code:
54312
Product Label ID:
827ec7b2-3d87-47e0-a47a-966b25732c32
FDA Application Number: [6]
M017
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
09-30-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 54312-825?

The NDC code 54312-825 is assigned by the FDA to the product Rocainol Topical Analgesic. It is commonly known by its generic name, methyl salicylate, menthol. This pharmaceutical product is labeled by Compania Internacional De Comercio, S.a.p.i De C.v. and is currently categorized as listed product. The medication is a ointment administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54312-825-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Apply on affected area not more than 3 or 4 times daily. Adults and children 12 years of age and older. Children under 12 years of age: consult a doctor

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MENTHOL 8 g/100g - A monoterpene cyclohexanol produced from mint oils.
  • METHYL SALICYLATE 16 g/100g - used in over-the-counter liniments, ointments, lotions for relief of musculoskeletal aches and pains; has hemolytic effect on human & sheep erythrocytes; RN given refers to parent cpd; structure in Merck Index, 9th ed, #5990

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1306905 - menthol 8 % / methyl salicylate 16 % Topical Ointment
  • RxCUI: 1306905 - menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment
  • RxCUI: 1306910 - Rocainol 8 % / 16 % Topical Ointment
  • RxCUI: 1306910 - menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical Ointment [Rocainol]
  • RxCUI: 1306910 - Rocainol (menthol 8 % / methyl salicylate 16 % ) Topical Ointment

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".