61077-501 NDC - H-ALLERGY FORMULA (ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDES)

Drug Information

Product NDC: 61077-501
Proprietary Name: H-Allergy Formula
Non Proprietary Name: allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, kali bichromicum, natrum muriaticum, solidago virgaurea, sticta pulmonaria, sulphur, trifolium pratense, wyethia helenioides
Active Ingredient(s): 10 [hp_X]/59mL AMBROSIA ARTEMISIIFOLIA; 10 [hp_X]/59mL ARISAEMA TRIPHYLLUM ROOT; 10 [hp_X]/59mL ARUNDO PLINIANA ROOT; 10 [hp_X]/59mL EUPHRASIA STRICTA; 10 [hp_X]/59mL GALPHIMIA GLAUCA FLOWERING TOP; 10 [hp_X]/59mL HISTAMINE DIHYDROCHLORIDE; 10 [hp_X]/59mL LOBARIA PULMONARIA; 10 [hp_X]/59mL ONION; 10 [hp_X]/59mL POTASSIUM DICHROMATE; 10 [hp_X]/59mL SODIUM CHLORIDE; 10 [hp_X]/59mL SOLIDAGO VIRGAUREA FLOWERING TOP; 10 [hp_X]/59mL SULFUR; 10 [hp_X]/59mL TRIFOLIUM PRATENSE FLOWER; 10 [hp_X]/59mL WYETHIA HELENIOIDES ROOT
Administration Route(s): ORAL
Dosage Form(s): SPRAY
Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Vegetable Proteins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Healing Natural Oils LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	4/7/2026

Package Information

No.	Package Code	Package Description	Billing Unit
1	61077-501-59	59 mL in 1 BOTTLE, SPRAY (61077-501-59)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	61077-501	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.
PRODUCT TYPE NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	H-Allergy Formula	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	allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, kali bichromicum, natrum muriaticum, solidago virgaurea, sticta pulmonaria, sulphur, trifolium pratense, wyethia helenioides	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SPRAY	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	4/7/2026	This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
LABELER NAME	Healing Natural Oils LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LOBARIA PULMONARIA; ONION; POTASSIUM DICHROMATE; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TRIFOLIUM PRATENSE FLOWER; WYETHIA HELENIOIDES ROOT	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10
ACTIVE INGRED UNIT	[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
PHARM CLASSES	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]

Drug Information

Labeler Information

Package Information

NDC Record

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