FDA.reportPublic FDA data

Bach Original Flower Remedies Gorse

Product NDC
57687-212
Requested package NDC
57687-212-10
11-digit product format
576870212
Labeler code
57687
Product ID
57687-212_e9d5553c-92d2-2fc8-e053-2995a90a050e
Type
HUMAN OTC DRUG
Nonproprietary name
Ulex europaeus
Dosage form
SOLUTION
Route
ORAL
Labeler
Nelson Bach USA Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-09-20
Substance
ULEX EUROPAEUS FLOWER
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 Gorse
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ULEX EUROPAEUS FLOWER5 [hp_X]/.095mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
398DBS1PXNInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e9d5553c-92d1-2fc8-e053-2995a90a050eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-212-10Bach Hope and Joy Comfort Kit1 in 1 CARTONSOLUTION5 [hp_X] in 0.095mL1
57687-212-10Bach Original Flower Remedies Gorse1 in 1 CARTONSOLUTION11
57687-212-10Bach Original Flower Remedies Gorse10 mL in 1 BOTTLE, DROPPERSOLUTION101
57687-212-10Bach Hope and Joy Comfort Kit10 mL in 1 BOTTLE, DROPPERSOLUTION10 mL5 [hp_X] in 0.095mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-212BACH 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
57687-212BACH ORIGINAL FLOWER REMEDIES GORSE (ULEX EUROPAEUS) SOLUTION [NELSON BACH USA LIMITED]1Current NDC, Legacy NDC, 2 package rows20221001_e9d5553c-92d1-2fc8-e053-2995a90a050e.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): 57687-212-10
ndc11 (package): 57687021210
Bach Original Flower Remedies GorseULEX EUROPAEUSNelson Bach USA Limitede9d5553c-92d1-2fc8-e053-2995a90a050e2022-09-29WarningsExact identifier
ndc (package): 57687-212-10
ndc (product): 57687-212
ndc11 (package): 57687021210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57687-212-10576870212101 BOTTLE, DROPPER in 1 CARTON (57687-212-10) / 10 mL in 1 BOTTLE, DROPPER2022-09-200000-00-00NoNoCurrent