NDC 55714-2212 Hay Fever

Zerophyllum Asphodeloides, Alfalfa, Avena Sativa Pollen, Cynosurus Cristatus Pollen, Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen, Alopecurus Pratensis Pollen, Phleum Pratense Pollen, Festuca Pratensis Pollen, Holcus Lanatus Pollen, Lolium Perenne Pollen, Fagus Sylvatica Pollen, Betula Pendula Pollen, Quercus Alba Pollen, Fraxinus Excelsior Pollen, Corylus Americana Pollen, Populus Nigra Pollen

NDC Product Code 55714-2212

NDC Code: 55714-2212

Proprietary Name: Hay Fever 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: Zerophyllum Asphodeloides, Alfalfa, Avena Sativa Pollen, Cynosurus Cristatus Pollen, Echinochloa Crus-galli Pollen, Poa Pratensis Pollen, Anthoxanthum Odoratum Pollen, Agrostis Gigantea Pollen, Bromus Secalinus Pollen, Alopecurus Pratensis Pollen, Phleum Pratense Pollen, Festuca Pratensis Pollen, Holcus Lanatus Pollen, Lolium Perenne Pollen, Fagus Sylvatica Pollen, Betula Pendula Pollen, Quercus Alba Pollen, Fraxinus Excelsior Pollen, Corylus Americana Pollen, Populus Nigra Pollen 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-2212 - Hay Fever

NDC 55714-2212-0

Package Description: 15 mL in 1 BOTTLE, GLASS

NDC 55714-2212-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC 55714-2212-2

Package Description: 59 mL in 1 BOTTLE, GLASS

NDC Product Information

Hay Fever with NDC 55714-2212 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Hay Fever is zerophyllum asphodeloides, alfalfa, avena sativa pollen, cynosurus cristatus pollen, echinochloa crus-galli pollen, poa pratensis pollen, anthoxanthum odoratum pollen, agrostis gigantea pollen, bromus secalinus pollen, alopecurus pratensis pollen, phleum pratense pollen, festuca pratensis pollen, holcus lanatus pollen, lolium perenne pollen, fagus sylvatica pollen, betula pendula pollen, quercus alba pollen, fraxinus excelsior pollen, corylus americana pollen, populus nigra pollen. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

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.

Hay Fever 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.

  • XEROPHYLLUM ASPHODELOIDES 30 [hp_X]/mL
  • ALFALFA 15 [hp_X]/mL
  • AVENA SATIVA POLLEN 15 [hp_X]/mL
  • CYNOSURUS CRISTATUS POLLEN 15 [hp_X]/mL
  • ECHINOCHLOA CRUS-GALLI POLLEN 15 [hp_X]/mL
  • POA PRATENSIS POLLEN 15 [hp_X]/mL
  • ANTHOXANTHUM ODORATUM POLLEN 15 [hp_X]/mL
  • AGROSTIS GIGANTEA POLLEN 15 [hp_X]/mL
  • BROMUS SECALINUS POLLEN 15 [hp_X]/mL
  • ALOPECURUS PRATENSIS POLLEN 15 [hp_X]/mL
  • PHLEUM PRATENSE POLLEN 15 [hp_X]/mL
  • FESTUCA PRATENSIS POLLEN 15 [hp_X]/mL
  • HOLCUS LANATUS POLLEN 15 [hp_X]/mL
  • LOLIUM PERENNE POLLEN 15 [hp_X]/mL
  • FAGUS SYLVATICA POLLEN 15 [hp_X]/mL
  • BETULA PENDULA POLLEN 15 [hp_X]/mL
  • QUERCUS ALBA POLLEN 15 [hp_X]/mL
  • FRAXINUS EXCELSIOR POLLEN 15 [hp_X]/mL
  • CORYLUS AMERICANA POLLEN 15 [hp_X]/mL
  • POPULUS NIGRA POLLEN 15 [hp_X]/mL
  • PLATANUS ORIENTALIS POLLEN 15 [hp_X]/mL
  • ULMUS GLABRA POLLEN 15 [hp_X]/mL
  • SALIX ALBA POLLEN 15 [hp_X]/mL
  • NARCISSUS PSEUDONARCISSUS 15 [hp_X]/mL
  • ROSA CANINA FLOWER 15 [hp_X]/mL
  • LILIUM CANDIDUM FLOWER 15 [hp_X]/mL
  • PRIMULA VULGARIS 15 [hp_X]/mL
  • DIANTHUS CARYOPHYLLUS FLOWER 15 [hp_X]/mL
  • ULEX EUROPAEUS FLOWER 15 [hp_X]/mL
  • CYTISUS SCOPARIUS POLLEN 15 [hp_X]/mL
  • CALLUNA VULGARIS POLLEN 15 [hp_X]/mL
  • CRATAEGUS MONOGYNA POLLEN 15 [hp_X]/mL
  • ACONITUM NAPELLUS 15 [hp_X]/mL
  • ARUNDO PLINIANA ROOT 15 [hp_X]/mL
  • DYSPHANIA AMBROSIOIDES 15 [hp_X]/mL
  • HELIANTHEMUM CANADENSE 15 [hp_X]/mL
  • DROSERA ROTUNDIFOLIA 15 [hp_X]/mL
  • SOLANUM DULCAMARA TOP 15 [hp_X]/mL
  • LEDUM PALUSTRE TWIG 15 [hp_X]/mL
  • ONOSMODIUM VIRGINIANUM WHOLE 15 [hp_X]/mL
  • POPULUS TREMULOIDES LEAF 15 [hp_X]/mL
  • POPULUS TREMULOIDES BARK 15 [hp_X]/mL
  • PULSATILLA VULGARIS 15 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 15 [hp_X]/mL
  • DATURA STRAMONIUM 15 [hp_X]/mL
  • ELYMUS REPENS ROOT 15 [hp_X]/mL
  • URTICA URENS 15 [hp_X]/mL
  • WYETHIA HELENIOIDES ROOT 15 [hp_X]/mL
  • ONION 15 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 15 [hp_X]/mL
  • AMMONIUM CARBONATE 15 [hp_X]/mL
  • ARALIA RACEMOSA ROOT 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • ARTEMISIA VULGARIS ROOT 15 [hp_X]/mL
  • BELLIS PERENNIS 15 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 15 [hp_X]/mL
  • EUPHRASIA STRICTA 15 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL
  • CALCIUM SULFIDE 15 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 15 [hp_X]/mL
  • POTASSIUM DICHROMATE 15 [hp_X]/mL
  • POTASSIUM IODIDE 15 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • SODIUM CHLORIDE 15 [hp_X]/mL
  • SCHOENOCAULON OFFICINALE SEED 15 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 15 [hp_X]/mL
  • TRILLIUM ERECTUM ROOT 15 [hp_X]/mL
  • USTILAGO MAYDIS 15 [hp_X]/mL
  • APIS MELLIFERA 3 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • GOLDENSEAL 3 [hp_X]/mL
  • TARAXACUM OFFICINALE 3 [hp_X]/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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: Newton Laboratories, Inc.
Labeler Code: 55714
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: 03-01-2011 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: 12-31-2019 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.

Hay Fever Product Label Images

Hay Fever 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

Indications & Usage Section

Hay Fever  Formulated for associated symptoms of late Summer and Fall pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Xerophyllum 30x, Alfalfa 15x, Allersodes 15x, Allium cepa 15x, Ambrosia 15x, Ammon. carb. 15x, Aralia rac. 15x, Arsenicum alb. 15x, Artemisia 15x, Bellis 15x, Berber. vulg. 15x, Bryonia 15x , Chelidonium maj. 15x, Eupatorium perf. 15x, Euphrasia 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Nat.mur. 15x, Sabadilla 15x, Solidago 15x, Trillium 15x, Ustilago maidis 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Taraxacum 3x.

Otc - Purpose Section

Formulated for associated symptoms of late Summer and Fall pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions Section

Www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning:  Keep out of reach of children.  Do not use if tamper-evident seal is broken or missing.  If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

Otc - Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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