FDA.reportPublic FDA data

Bach Original Flower Remedies Star of Bethlehem

Product NDC
57687-228
Requested package NDC
57687-228-10
11-digit product format
576870228
Labeler code
57687
Product ID
57687-228_ea2638fa-8f4d-e378-e053-2995a90afaac
Type
HUMAN OTC DRUG
Nonproprietary name
Ornithogalum umbellatum
Dosage form
SOLUTION
Route
ORAL
Labeler
Nelson Bach USA Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-09-20
Substance
ORNITHOGALUM UMBELLATUM FLOWERING TOP
Active strength
5 [hp_X]/.095mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Bach Original Flower Remedies Star of Bethlehem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORNITHOGALUM UMBELLATUM FLOWERING TOP5 [hp_X]/.095mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CZD6M4PY4BInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea2638fa-8f4c-e378-e053-2995a90afaacAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-228-10Bach Original Flower Remedies Star of Bethlehem1 in 1 CARTONSOLUTION11
57687-228-10Bach Hope and Joy Comfort Kit10 mL in 1 BOTTLE, DROPPERSOLUTION10 mL5 [hp_X] in 0.095mL1
57687-228-10Bach Hope and Joy Comfort Kit1 in 1 CARTONSOLUTION5 [hp_X] in 0.095mL1
57687-228-10Bach Original Flower Remedies Star of Bethlehem10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-228BACH HOPE AND JOY COMFORT KIT (STAR OF BETHLEHEM, GORSE, SWEET CHESTNUT) KIT [NELSON BACH USA LIMITED]1Current NDC, Legacy NDC20231101_074d88a8-a879-f65c-e063-6394a90a3cda.zip
57687-228BACH ORIGINAL FLOWER REMEDIES STAR OF BETHLEHEM (ORNITHOGALUM UMBELLATUM) SOLUTION [NELSON BACH USA LIMITED]1Current NDC, Legacy NDC, 2 package rows20221004_ea2638fa-8f4c-e378-e053-2995a90afaac.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bach Hope and Joy Comfort KitSTAR OF BETHLEHEM, GORSE, SWEET CHESTNUTNelson Bach USA Limited074d88a8-a879-f65c-e063-6394a90a3cda2023-10-16WarningsExact identifier
ndc (package): 57687-228-10
ndc11 (package): 57687022810
Bach Original Flower Remedies Star of BethlehemORNITHOGALUM UMBELLATUMNelson Bach USA Limitedea2638fa-8f4c-e378-e053-2995a90afaac2022-10-03WarningsExact identifier
ndc (package): 57687-228-10
ndc (product): 57687-228
ndc11 (package): 57687022810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57687-228-10576870228101 BOTTLE, DROPPER in 1 CARTON (57687-228-10) / 10 mL in 1 BOTTLE, DROPPER2022-09-200000-00-00NoNoCurrent