FDA.reportPublic FDA data

BM Crataegus Oxy

Manufacturer
BM Private Limited
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:14

Label at a glance#

ProductBM Crataegus Oxy
Active ingredientCRATAEGUS FRUIT
Label structure10 sections

Storage and handling

Precautions/storage: Keep away from children and store at cool and dry place.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CRATAEGUS OXYACANTHA

INACTIVE INGREDIENT SECTION

ALCOHOL, WATER

INDICATIONS & USAGE SECTION

Indications & dosage: As advised by a homoeopathic physician.

DOSAGE & ADMINISTRATION SECTION

Indications & dosage: As advised by a homoeopathic physician.

OTC - PURPOSE SECTION

Indications & dosage: As advised by a homoeopathic physician.

CONTRAINDICATIONS SECTION

Care & contra-indications: This is a homoeopathic product, no contra-indications are established.

WARNINGS SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

STORAGE AND HANDLING SECTION

Precautions/storage: Keep away from children and store at cool and dry place.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire package label

crataeguscrataegus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-5123-1BM Crataegus Oxy30 mL in 1 BOTTLE, GLASSTINCTURE301

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85816-512385816-5123-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CRATAEGUS FRUITQ21UUL2105ACTIB
ALCOHOL3K9958V90MIACT

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
BM Crataegus OxyCRATAEGUS OXYBM Private Limited38db86ca-917e-d6b4-e063-6294a90a0cc72025-07-01WarningsExact identifier
ndc (package): 85816-5123-1
ndc (product): 85816-5123
ndc11 (package): 85816512301
spl id: 38db86ca-917f-d6b4-e063-6294a90a0cc7
spl set id: 38db86ca-917e-d6b4-e063-6294a90a0cc7

Reported adverse events (FAERS/openFDA)#

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