FDA.reportPublic FDA data

Dysfunctional Bleeding Drops

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:49:35

Label at a glance#

ProductDysfunctional Bleeding Drops 2138
Active ingredientBOS TAURUS HYPOTHALAMUS, BEEF LIVER, BOS TAURUS OVARY, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS SPLEEN, SUS SCROFA UTERUS, CHASTE TREE FRUIT, COFFEA ARABICA SEED, ROASTED, CALENDULA OFFICINALIS FLOWERING TOP, GOLDENSEAL, CAPSELLA BURSA-PASTORIS WHOLE, CHAMAELIRIUM LUTEUM ROOT, SILICON DIOXIDE, TRIFOLIUM PRATENSE FLOWER, VIBURNUM OPULUS BARK, APIS MELLIFERA, SELENICEREUS GRANDIFLORUS STEM, COLLINSONIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, VERATRUM ALBUM 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

Hypothalamus 6X
Liver 6X
Ovary 6X
Pituitary 6X
Spleen 6X
Uterus 6X
Agnus castus 8X
Coffea tosta 8X
Calendula officinalis 9X
Hydrastis canadensis 9X
Capsella bursa-pastoris 12X
Endometritis tuberculosa 12X
Helonias luteum 12X
Silicea 12X
Trifolium pratense 12X
Viburnum opulus 12X
Apis mellifica 30X
Cactus grandiflorus 30X
Collinsonia canadensis 30X
Gelsemium sempervirens 30X
Nux vomica 30X
Veratrum album 30X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of occasional mild spotting or menstrual irregularity.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

Any significant vaginal bleeding or change in menstrual pattern requires evaluation by a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

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

Dysfunctional Bleeding Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2138-22026-01-09C16284748780-11030e365-4e09-111a-e063-dadaa90a10e2C138
63083-2138-22026-01-09C16284748780-11030e365-4e09-111a-e063-dadaa90a10e2C138
63083-2138-22024-01-30C16284748780-11030e365-4e09-111a-e063-dadaa90a10e2C138
63083-2138-22024-01-30C16284748780-11030e365-4e09-111a-e063-dadaa90a10e2C138

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2138-2Dysfunctional Bleeding Drops213859 mL in 1 BOTTLE, DROPPERLIQUID592

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-213863083-2138-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
BEEF LIVERW8N8R55022ACTIB
BOS TAURUS OVARY66LZN1C747ACTIB
BOS TAURUS PITUITARY GLAND, POSTERIOR7JM57I419KACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
SUS SCROFA UTERUS2595C75F1PACTIB
CHASTE TREE FRUIT433OSF3U8AACTIB
COFFEA ARABICA SEED, ROASTED9H58JRT35EACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
GOLDENSEALZW3Z11D0JVACTIB
CAPSELLA BURSA-PASTORIS WHOLEW0X9457M59ACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
COLLINSONIA CANADENSIS ROOTO2630F3XDRACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:16:17

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
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
ndc (package): 63083-2138-2
ndc (product): 63083-2138
ndc11 (package): 63083213802
spl id: c3fc01bd-99ed-42e3-a6c9-e9a9bad9b527
spl set id: 3e674c1e-c64b-416d-962f-c03493e80085

Reported adverse events (FAERS/openFDA)#

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