FDA.reportPublic FDA data

BM Calendula Officinalis Spray

Manufacturer
BM Private Limited
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:12

Label at a glance#

ProductBM Calendula Officinalis
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

calendula officinalis

INACTIVE INGREDIENT SECTION

purified water and alcohol

DOSAGE & ADMINISTRATION SECTION

Indications & dosage:
Referred to enclosed self help guide or as advised by a homoeopathic physician.

INDICATIONS & USAGE SECTION

Indications & dosage:
Referred to enclosed self help guide or as advised by a homoeopathic physician.

OTC - PURPOSE SECTION

Indications & dosage:
Referred to enclosed self help guide or as advised by a homoeopathic physician.

CONTRAINDICATIONS SECTION

Care & contra-indications:
This is a homoeopathic remedy, 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire package label

calendulacalendula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6018-1BM Calendula Officinalis30 mL in 1 BOTTLE, SPRAYSPRAY301

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
85816-601885816-6018-1

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
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
WATER059QF0KO0RIACT
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 Calendula OfficinalisCALENDULA OFFICINALISBM Private Limited38913db4-fb8a-854f-e063-6294a90a185e2025-06-27WarningsExact identifier
ndc (package): 85816-6018-1
ndc (product): 85816-6018
ndc11 (package): 85816601801
spl id: 38913db4-fb8b-854f-e063-6294a90a185e
spl set id: 38913db4-fb8a-854f-e063-6294a90a185e

Reported adverse events (FAERS/openFDA)#

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