H-calm Formula Spray
NDC 61077-502

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 61077-502?
  4. H-calm Formula Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

H-calm Formula (aconitum napellus, alfalfa, avena sativa, chamomilla, cistus canadensis, clematis vitalba, flos, impatiens glandulifera, flos, kali phosphoricum, lilium tigrinum, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, pulsatilla, valeriana officinalis) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Healing Natural Oils Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a spray for oral administration. This product entry covers the primary NDC 61077-502 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
61077-502
Proprietary Name:
H-calm Formula
Non-Proprietary Name: [1]
Aconitum Napellus, Alfalfa, Avena Sativa, Chamomilla, Cistus Canadensis, Clematis Vitalba, Flos, Impatiens Glandulifera, Flos, Kali Phosphoricum, Lilium Tigrinum, Ornithogalum Umbellatum, Flos, Passiflora Incarnata, Phosphorus, Prunus Cerasifera, Flos, Pulsatilla, Valeriana Officinalis
Substance Name: [2]
Aconitum Napellus; Alfalfa; Avena Sativa Flowering Top; Clematis Vitalba Flower; Crocanthemum Canadense; Dibasic Potassium Phosphate; Impatiens Glandulifera Flower; Lilium Lancifolium Whole Flowering; Matricaria Chamomilla Whole; Ornithogalum Umbellatum Flowering Top; Passiflora Incarnata Flowering Top; Phosphorus; Prunus Cerasifera Flower; Pulsatilla Vulgaris Whole; Valerian
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Healing Natural Oils Llc
Labeler Code:
61077
Product Label ID:
4ee311e9-626a-a73c-e063-6294a90a773b
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
04-07-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 61077-502?

The NDC code 61077-502 is assigned by the FDA to the product H-calm Formula. It is commonly known by its generic name, aconitum napellus, alfalfa, avena sativa, chamomilla, cistus canadensis, clematis vitalba, flos, impatiens glandulifera, flos, kali phosphoricum, lilium tigrinum, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, pulsatilla, valeriana officinalis. This pharmaceutical product is labeled by Healing Natural Oils Llc and is currently categorized as listed product. The medication is a spray administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 61077-502-59. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Depress pump to primeSpray one dose directly into mouthAdults & children over 12 years: 3 sprays 3 times per dayChildren 6-12 years: 2 sprays 3 times per dayConsult a physician for use in children under 6 years oldUse additionally as needed, up to 6 times per day

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • CROCANTHEMUM CANADENSE (UNII: 46G3W789Q3)
  • CROCANTHEMUM CANADENSE (UNII: 46G3W789Q3) (Active Moiety)
  • PHOSPHORUS (UNII: 27YLU75U4W)
  • PHOSPHORUS (UNII: 27YLU75U4W) (Active Moiety)
  • MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
  • MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (Active Moiety)
  • ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B)
  • ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (Active Moiety)
  • LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI)
  • LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (Active Moiety)
  • VALERIAN (UNII: JWF5YAW3QW)
  • VALERIAN (UNII: JWF5YAW3QW) (Active Moiety)
  • DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
  • PHOSPHATE ION (UNII: NK08V8K8HR) (Active Moiety)
  • ACONITUM NAPELLUS (UNII: U0NQ8555JD)
  • ACONITUM NAPELLUS (UNII: U0NQ8555JD) (Active Moiety)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O)
  • PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (Active Moiety)
  • PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV)
  • PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (Active Moiety)
  • IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV)
  • IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (Active Moiety)
  • PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS)
  • PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (Active Moiety)
  • AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)
  • AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (Active Moiety)
  • ALFALFA (UNII: DJO934BRBD)
  • ALFALFA (UNII: DJO934BRBD) (Active Moiety)
  • CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI)
  • CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".