NDC 55714-2596-1 HUMAN OTC DRUG

Drug Status:  Active

Proprietary Name: Immu-n Waker

Drug Overview

The NDC Code 55714-2596-1 is assigned to “Immu-n Waker ” (also known as: “Apis Mel, Echinacea, Hydrastis, Thuja Occ, Aconitum Nap, Agaricus Musc, Allium Sat, Aloe, Arnica, Arsenicum Alb, Baptisia, Belladonna, Bryonia, Calc Carb, Calendula, Capsicum, Carduus Mar, Hepar Sulph Calc, Iodium, Lachesis, Lycopodium, Mercurius Viv, Nux Vom, Phos, Pulsatilla, Rhus Tox, Salvia, Selenium, Taraxacum, Tarentula Hisp, Zinc Met, Zingiber, Anthracinum, Azadirachta, Influenzinum”), a human otc drug labeled by “Newton Laboratories, Inc.”. The product's dosage form is liquid, and is administered via oral form.

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Drug Information
NDC Package Code	55714-2596-1
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	55714-2596
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	55714-2596-01
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Immu-n Waker
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Apis Mel Echinacea Hydrastis Thuja Occ Aconitum Nap Agaricus Musc Allium Sat Aloe Arnica Arsenicum Alb Baptisia Belladonna Bryonia Calc Carb Calendula Capsicum Carduus Mar Hepar Sulph Calc Iodium Lachesis Lycopodium Mercurius Viv Nux Vom Phos Pulsatilla Rhus Tox Salvia Selenium Taraxacum Tarentula Hisp Zinc Met Zingiber Anthracinum Azadirachta Influenzinum
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN OTC DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Newton Laboratories, Inc.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Indication And Usage	Formulated for symptoms such as hypersensitivity, debility, glandular swellings, infections and inflammation.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	LIQUID
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	ORAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], BEE VENOMS [CS], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], DIETARY PROTEINS [CS], DIETARY PROTEINS [CS], DIETARY PROTEINS [CS], DIETARY PROTEINS [CS], FOOD ADDITIVES [CS], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED IGG PRODUCTION [PE], INCREASED IGG PRODUCTION [PE], NON-STANDARDIZED FOOD ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED FOOD ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED FOOD ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED FOOD ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED PLANT ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED PLANT ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED PLANT ALLERGENIC EXTRACT [EPC], NON-STANDARDIZED PLANT ALLERGENIC EXTRACT [EPC], PLANT PROTEINS [CS], PLANT PROTEINS [CS], PLANT PROTEINS [CS], PLANT PROTEINS [CS], PLANT PROTEINS [CS], SEED STORAGE PROTEINS [CS], STANDARDIZED INSECT VENOM ALLERGENIC EXTRACT [EPC], VEGETABLE PROTEINS [CS]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	ACONITUM NAPELLUS - 15 [hp_X]/mL ALOE (Substance Adverse Reports) - 15 [hp_X]/mL AMANITA MUSCARIA FRUITING BODY (Substance Adverse Reports) - 15 [hp_X]/mL ANEMONE PULSATILLA (Substance Adverse Reports) - 15 [hp_X]/mL APIS MELLIFERA (Substance Adverse Reports) - 6 [hp_X]/mL ARNICA MONTANA (Substance Adverse Reports) - 15 [hp_X]/mL ARSENIC TRIOXIDE (Substance Adverse Reports) - 15 [hp_X]/mL ATROPA BELLADONNA (Substance Adverse Reports) - 15 [hp_X]/mL AZADIRACHTA INDICA BARK (Substance Adverse Reports) - 16 [hp_X]/mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT (Substance Adverse Reports) - 16 [hp_X]/mL BAPTISIA TINCTORIA ROOT (Substance Adverse Reports) - 15 [hp_X]/mL BRYONIA ALBA ROOT (Substance Adverse Reports) - 15 [hp_X]/mL CALCIUM SULFIDE (Substance Adverse Reports) - 15 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP (Substance Adverse Reports) - 15 [hp_X]/mL CAPSICUM (Substance Adverse Reports) - 15 [hp_X]/mL ECHINACEA, UNSPECIFIED (Substance Adverse Reports) - 6 [hp_X]/mL GARLIC (Substance Adverse Reports) - 15 [hp_X]/mL GINGER (Substance Adverse Reports) - 15 [hp_X]/mL GOLDENSEAL (Substance Adverse Reports) - 6 [hp_X]/mL INFLUENZA A VIRUS (Substance Adverse Reports) - 30 [hp_X]/mL INFLUENZA B VIRUS (Substance Adverse Reports) - 30 [hp_X]/mL IODINE (Substance Adverse Reports) - 15 [hp_X]/mL LACHESIS MUTA VENOM (Substance Adverse Reports) - 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE (Substance Adverse Reports) - 15 [hp_X]/mL LYCOSA TARANTULA (Substance Adverse Reports) - 15 [hp_X]/mL MERCURY (Substance Adverse Reports) - 15 [hp_X]/mL MILK THISTLE (Substance Adverse Reports) - 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (Substance Adverse Reports) - 15 [hp_X]/mL PHOSPHORUS (Substance Adverse Reports) - 15 [hp_X]/mL SAGE (Substance Adverse Reports) - 15 [hp_X]/mL SELENIUM (Substance Adverse Reports) - 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED (Substance Adverse Reports) - 15 [hp_X]/mL TARAXACUM OFFICINALE (Substance Adverse Reports) - 15 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG (Substance Adverse Reports) - 6 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF (Substance Adverse Reports) - 15 [hp_X]/mL ZINC (Substance Adverse Reports) - 15 [hp_X]/mL
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	55714-2596-1
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	30 ML IN 1 BOTTLE, GLASS (55714-2596-1)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20250521
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	55714-2596
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	N/S (NOT SPECIFIED)
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	UNAPPROVED HOMEOPATHIC
	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.
Listing Record Certified Through	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20250521
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This 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.

Tracking Information
Last Update Date	2025-05-22
	The date that a record was last updated or changed.