Pv Ultra Zinc Cold Therapy
NDC 68016-692

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pv Ultra Zinc Cold Therapy is a UNAPPROVED HOMEOPATHIC-approved product labeled by Pharmacy Value Alliance, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 68016-692 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68016-692
Proprietary Name:
Pv Ultra Zinc Cold Therapy
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
68016
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
01-20-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
15 MM
Imprint(s):
RP118
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 68016-692?

The NDC code 68016-692 is assigned by the FDA to the product Pv Ultra Zinc Cold Therapy. This pharmaceutical product is labeled by Pharmacy Value Alliance, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68016-692-18. 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?

▪for best results, use at the first sign of a cold and continue to use as directed▪adults and children 12 years of age and older:▪chew one tablet completely at the onset of symptoms. Do not swallow tablets whole.▪repeat every 3 hours until symptoms are gone▪to avoid minor stomach upset, do not take on an empty stomach.▪do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.▪recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17▪Children under 12 years of age: Consult a doctor before use.

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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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".