FDA.reportPublic FDA data

Lactation Calm

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2019-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:16:22

Label at a glance#

ProductLactation Calm 2150
Active ingredientARTEMISIA ANNUA FLOWERING TOP, BOS TAURUS HYPOTHALAMUS, BOS TAURUS LYMPH VESSEL, SUS SCROFA MAMMARY GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, SILICON DIOXIDE, AMARYLLIS BELLADONNA WHOLE, BRYONIA ALBA ROOT, URTICA URENS WHOLE, CONIUM MACULATUM FLOWERING TOP, CANIS LUPUS FAMILIARIS MILK, PHYTOLACCA AMERICANA ROOT
Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 3X
Hypothalamus 6X
Lymph 6X
Mammary 6X
Pituitary 6X
Silicea 6X
Belladonna 9X
Bryonia 9X
Urtica urens 9X
Conium maculatum 12X
Lac caninum 12X
Phytolacca decandra 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For temporary assistance with excessive lactation.*

OTC - PURPOSE SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

WARNINGS SECTION

In case of overdose, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Lactation Calm

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2150-22026-01-08C16284748780-11030e365-3f52-111a-e063-dadaa90a10e2C150
63083-2150-22024-01-30C16284748780-11030e365-3f52-111a-e063-dadaa90a10e2C150

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2150LACTATION CALM 2150 (LACTATION CALM) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Legacy NDC20220215_901a0b81-3548-4bda-8c19-d71848125635.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-215063083-2150-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARTEMISIA ANNUA FLOWERING TOP0UQK6O82OWACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
BOS TAURUS LYMPH VESSEL85I1Z426OVACTIB
SUS SCROFA MAMMARY GLAND692OX2DX0EACTIB
BOS TAURUS PITUITARY GLAND, POSTERIOR7JM57I419KACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
AMARYLLIS BELLADONNA WHOLE11B89M58UNACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CANIS LUPUS FAMILIARIS MILKG39P120JQTACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
3d182ee8-4e9a-424a-9239-7b00ce397d82901a0b81-3548-4bda-8c19-d718481256352026-01-08WarningsExact identifier
spl set id: 901a0b81-3548-4bda-8c19-d71848125635

Reported adverse events (FAERS/openFDA)#

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