NDC 0363-4801 Childrens Allergy Dye Free Wal-dryl

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0363-4801
Proprietary Name:
Childrens Allergy Dye Free Wal-dryl
Product Type: [3]
Labeler Name: [5]
Labeler Code:
0363
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
10-01-2018
End Marketing Date: [10]
06-21-2024
Listing Expiration Date: [11]
06-21-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
12 MM
Imprint(s):
44;480
Score:
1
Flavor(s):
GRAPE (C73391)

Code Structure Chart

Product Details

What is NDC 0363-4801?

The NDC code 0363-4801 is assigned by the FDA to the product Childrens Allergy Dye Free Wal-dryl which is product labeled by Walgreen Company. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0363-4801-09 4 blister pack in 1 carton / 5 tablet, chewable in 1 blister pack. 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 Childrens Allergy Dye Free Wal-dryl?

Find right dose on chart belowchew or crush tablets completely before swallowing; do not swallow tablets wholetake every 4 to 6 hours, or as directed by a doctordo not take more than 6 times in 24 hoursAge (yr)Dose (chewable tablets)children under 2 yearsdo not usechildren 2 to 5 years do not use unlessdirected by a doctorchildren 6 to 11 years1 to 2 chewable tablets(12.5 mg to 25 mg)adults and children 12 years and over2 to 4 chewable tablets (25 mg to 50 mg)

Which are Childrens Allergy Dye Free Wal-dryl UNII Codes?

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

  • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
  • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

Which are Childrens Allergy Dye Free Wal-dryl 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:

What is the NDC to RxNorm Crosswalk for Childrens Allergy Dye Free Wal-dryl?

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:

* Please review the disclaimer below.

Patient Education

Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
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Product Footnotes

[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.

[11] 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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".