NDC 54973-3405 Canker Sore Relief Rinse

Goldenseal, Myrrh, Echinacea Angustifolia And Sodium Chloride

NDC Product Code 54973-3405

NDC 54973-3405-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 236 mL in 1 BOTTLE, PLASTIC

NDC 54973-3405-2

Package Description: 5 mL in 1 PACKET

NDC Product Information

Canker Sore Relief Rinse with NDC 54973-3405 is a a human over the counter drug product labeled by Hyland's. The generic name of Canker Sore Relief Rinse is goldenseal, myrrh, echinacea angustifolia and sodium chloride. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug 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.

Canker Sore Relief Rinse Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ECHINACEA ANGUSTIFOLIA 6 [hp_X]/mL
  • SODIUM CHLORIDE 30 [hp_X]/mL
  • MYRRH 4 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Hyland's
Labeler Code: 54973
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 11-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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Canker Sore Relief Rinse Product Label Images