NDC 54973-3012 Seasonal Allergy Relief

Onion, Sodium Chloride, Histamine Dihydrochloride, Cucumber, Galphimia Glauca Flowering Top, And Strychnos Nux-vomica Seed

NDC Product Code 54973-3012

NDC CODE: 54973-3012

Proprietary Name: Seasonal Allergy Relief 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: Onion, Sodium Chloride, Histamine Dihydrochloride, Cucumber, Galphimia Glauca Flowering Top, And Strychnos Nux-vomica Seed 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
5 MM
Score: 1

NDC Code Structure

  • 54973 - Hyland's

NDC 54973-3012-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 60 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

NDC Product Information

Seasonal Allergy Relief with NDC 54973-3012 is a a human over the counter drug product labeled by Hyland's. The generic name of Seasonal Allergy Relief is onion, sodium chloride, histamine dihydrochloride, cucumber, galphimia glauca flowering top, and strychnos nux-vomica seed. The product's dosage form is tablet, soluble and is administered via oral form.

Labeler Name: Hyland's

Dosage Form: Tablet, Soluble - A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids.

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.

Seasonal Allergy Relief 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.

  • ONION 6 [hp_X]/1
  • SODIUM CHLORIDE 6 [hp_X]/1
  • HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/1
  • CUCUMBER 12 [hp_X]/1
  • GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1

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.

  • ACACIA (UNII: 5C5403N26O)
  • LACTOSE (UNII: J2B2A4N98G)

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.
  • 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: 05-29-2002 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’.

* Please review the disclaimer below.

Seasonal Allergy Relief Product Label Images

Seasonal Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Purpose

For Indoor & Outdoor Allergies

Drug Facts

Drug Facts

Otc - Active Ingredient

Active IngredientsPurposeAllium Cepa 6X HPUShay fever, watery eyesGalphimia Glauca 12X HPUSsneezing, runny noseHistaminum Hydrochloricum 12X HPUSsinus painLuffa Operculata 12X HPUSsinus pain, headacheNatrum Muriaticum 6X HPUSsneezing, itchy eyesNux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)itchy nose & throat"HPUS" indicates the active ingredients are offiacial Homeopathic Pharmacopœia of the United States.

Uses

  • Temporarily relieves the symptoms of hay fever or other upper respiratory allergies from mold, animal dander, pollen, ragweed, and grasses.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. Stop use and ask a doctor if symptoms persist for more than 7 day or worsen.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of accidental overdose get medical help or contact a Poison Control Center immediately.

Otc - Do Not Use

Do not use if imprinted tamper band is broken or missing.

Otc - Questions

In case of emergency, Hyland's may be contacted 24 hours a day, 7 days a week at 800/624-9659

Adults And Children Over 12 Years

Dissolve 1 to 2 tablets under the tongue every 4 hours or as needed.

Inactive Ingredients

Acacia Gum, Lactose N.F.

* Please review the disclaimer below.