H-Calm Formula

Manufacturer
Healing Natural Oils LLC | King Bio Inc.
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:38:18

Label at a glance#

ProductH-Calm Formula
Active ingredientCROCANTHEMUM CANADENSE, PHOSPHORUS, MATRICARIA CHAMOMILLA WHOLE, ORNITHOGALUM UMBELLATUM FLOWERING TOP, LILIUM LANCIFOLIUM WHOLE FLOWERING, VALERIAN, DIBASIC POTASSIUM PHOSPHATE, ACONITUM NAPELLUS, PASSIFLORA INCARNATA FLOWERING TOP, PULSATILLA VULGARIS WHOLE, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, AVENA SATIVA FLOWERING TOP, ALFALFA, CLEMATIS VITALBA FLOWER
Label structure8 sections

Indications and uses

For temporary relief of symptoms such as: restlessness tension irritability agitation +as per various homeopathic materia medicas. Claims are based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evalutaed by the Food and Drug Administration. Product has not been clinically tested.

Dosage and administration

Depress pump to prime Spray one dose directly into mouth Adults & children over 12 years: 3 sprays 3 times per day Children 6-12 years: 2 sprays 3 times per day Consult a physician for use in children under 6 years old Use additionally as needed, up to 6 times per day

Storage and handling

Store at room temperature 68-77F (20-25C) Avoid direct sunlight and excessive heat Do not use if safety seal is broken or missing

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Aconitum napellus...........................Fear

Alfalfa...........................Vitality

Avena sativa...........................Exhaustion

Chamomilla...........................Irritability

Cistus canadensis...........................Apprehension

Clematis vitalba, flos...........................Dreaminess

Impatiens glandulifera, flos...........................Impatience

Kali phosphoricum...........................Fatigue

Lilium tigrinum...........................Anxiety

Ornithogalum umbellatum, flos...........................Shock

Passiflora incarnata...........................Nervousness

Phosphorus...........................Weakness

Prunus cerasifera, flos...........................Control

Pulsatilla...........................Moodiness

Valeriana officinalis...........................Restlessness

Uses

INDICATIONS & USAGE SECTION

For temporary relief of symptoms such as:

  • restlessness
  • tension
  • irritability
  • agitation

+as per various homeopathic materia medicas. Claims are based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evalutaed by the Food and Drug Administration. Product has not been clinically tested.

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

  • Stop use and consult a physician if symptoms worsen or persist for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast-feeding, ask a healthcare professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Depress pump to prime
  • Spray one dose directly into mouth
  • Adults & children over 12 years: 3 sprays 3 times per day
  • Children 6-12 years: 2 sprays 3 times per day
  • Consult a physician for use in children under 6 years old
  • Use additionally as needed, up to 6 times per day

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 68-77F (20-25C)
  • Avoid direct sunlight and excessive heat
  • Do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Potassium Sorbate, USP Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Calm Formula

Homeopathic

For temporary relief of:

Restlessness

Irritability

2 fl oz (59 mL)

amoils.com

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130811886015022GTIN-13: 0811886015022
EAN-13: 0811886015022
GTIN-12: 811886015022
UPC-A: 811886015022
GTIN storage (14 digits): 00811886015022
H-Calm Formula.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-502-59H-Calm Formula59 mL in 1 BOTTLE, SPRAYSPRAY591

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-50261077-502-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Calm FormulaACONITUM 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 OFFICINALISHealing Natural Oils LLC4ee311e9-626a-a73c-e063-6294a90a773b2026-04-07WarningsExact identifier
ndc (package): 61077-502-59
ndc (product): 61077-502
ndc11 (package): 61077050259
spl id: 4ee311e9-626b-a73c-e063-6294a90a773b
spl set id: 4ee311e9-626a-a73c-e063-6294a90a773b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.