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  4. NDC Product Code: 78371-201 Halodine Oral Rinse

NDC 78371-201 Halodine Oral Rinse

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 78371-201?
  4. Halodine Oral Rinse Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
78371-201
Proprietary Name:
Halodine Oral Rinse
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Halodine Llc
Labeler Code:
78371
Product Label ID:
a9ee4c33-4a5b-3a1f-e053-2995a90aa515
Start Marketing Date: [9]
05-15-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 78371-201-01

Package Description: 100 AMPULE in 1 CARTON / 3.2 mL in 1 AMPULE

NDC Code 78371-201-02

Package Description: 200 AMPULE in 1 CARTON / 3.8 mL in 1 AMPULE

NDC Code 78371-201-03

Package Description: 10 AMPULE in 1 CARTON / 3.2 mL in 1 AMPULE

Product Details

What is NDC 78371-201?

The NDC code 78371-201 is assigned by the FDA to the product Halodine Oral Rinse which is product labeled by Halodine Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 78371-201-01 100 ampule in 1 carton / 3.2 ml in 1 ampule, 78371-201-02 200 ampule in 1 carton / 3.8 ml in 1 ampule, 78371-201-03 10 ampule in 1 carton / 3.2 ml in 1 ampule. 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 Halodine Oral Rinse?

For oral antisepsis in adults and children 3 years of age and older:Twist off the narrow end of single ampoule.Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.Slightly lift chin and tilt head back to gargle, then spit out.Children under 3 years of age: Consult a dentist or doctor

Which are Halodine Oral Rinse UNII Codes?

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

Which are Halodine Oral Rinse 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 Halodine Oral Rinse?

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:

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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.

[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.

[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".