NDC 80046-001 Sinus Remedy

Calc Carb, Euphorbium, Hydrastis, Kali Bic, Kali Iod, Lycopodium, Phosphorus, Pulsatilla, Sanguinaria, Thuja Occ

NDC Product Code 80046-001

NDC CODE: 80046-001

Proprietary Name: Sinus Remedy What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calc Carb, Euphorbium, Hydrastis, Kali Bic, Kali Iod, Lycopodium, Phosphorus, Pulsatilla, Sanguinaria, Thuja Occ 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.

NDC Code Structure

  • 80046 - Sunset 20 Llc

NDC 80046-001-02

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Sinus Remedy with NDC 80046-001 is a a human over the counter drug product labeled by Sunset 20 Llc. The generic name of Sinus Remedy is calc carb, euphorbium, hydrastis, kali bic, kali iod, lycopodium, phosphorus, pulsatilla, sanguinaria, thuja occ. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Sunset 20 Llc

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.

Sinus Remedy 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.

  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 9 [hp_X]/30mL
  • EUPHORBIA RESINIFERA RESIN 6 [hp_X]/30mL
  • GOLDENSEAL 6 [hp_X]/30mL
  • POTASSIUM DICHROMATE 9 [hp_X]/30mL
  • POTASSIUM IODIDE 8 [hp_X]/30mL
  • LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/30mL
  • PHOSPHORUS 10 [hp_X]/30mL
  • PULSATILLA VULGARIS WHOLE 4 [hp_X]/30mL
  • SANGUINARIA CANADENSIS ROOT 9 [hp_X]/30mL
  • THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/30mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • CITRIC ACID ACETATE (UNII: DSO12WL7AU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Sunset 20 Llc
Labeler Code: 80046
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: 03-09-2021 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: 12-31-2022 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 - NO 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".

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