NDC 84673-003 Whitening

Ojw Brightening Serum Emulsion Auricular (otic); Buccal; Conjunctival; Cutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

Get all the details for National Drug Code (NDC) 84673-003 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
84673-003
Proprietary Name:
Whitening
Non-Proprietary Name: [1]
Ojw Brightening Serum
Substance Name: [2]
3-o-ethyl Ascorbic Acid; Niacinamide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route(s): [4]
  • Auricular (otic) - Administration to or by way of the ear.
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Conjunctival - Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball.
  • Cutaneous - Administration to the skin.
Labeler Code:
84673
FDA Application Number: [6]
505G(a)(3)
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
04-16-2024
End Marketing Date: [10]
04-16-2027
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 84673-003?

The NDC code 84673-003 is assigned by the FDA to the product Whitening which is a human over the counter drug product labeled by Guangzhou Meiya Cosmetics Co.. Ltd.. The generic name of Whitening is ojw brightening serum. The product's dosage form is emulsion and is administered via auricular (otic); buccal; conjunctival; cutaneous form. The product is distributed in a single package with assigned NDC code 84673-003-03 100 mg in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Whitening?

HOW TO USE :After cleansing the skin in the morning and evening, apply an appropriate amount of essence evenly to the face and massage it to absorb.

What are Whitening Active Ingredients?

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.
  • 3-O-ETHYL ASCORBIC ACID .15 g/mg
  • NIACINAMIDE 2 g/mg - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Which are Whitening UNII Codes?

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

Which are Whitening Inactive Ingredients 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:

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Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - 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.

[12] 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".