FDA.reportPublic FDA data

Bach Original Flower Remedies Rock Rose

Manufacturer
Nelson Bach USA Limited | A. Nelson & Co. Limited
Effective date
2022-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:13

Label at a glance#

ProductBach Original Flower Remedies Rock Rose
Active ingredientHELIANTHEMUM NUMMULARIUM FLOWER
Label structure9 sections

Dosage and administration

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day. Children under 2: ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Rock Rose (Helianthemum nummularium) 5X HPUS

‘HPUS’ indicates the ingredient is in the official Homeopathic Pharmacopoeia of the United States

Purpose

OTC - PURPOSE SECTION

Have courage

Use

INDICATIONS & USAGE SECTION

For relief of naturally occurring simple nervous tension

Warnings

WARNINGS SECTION

Consult a doctor if symptoms last for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.

Children under 2: ask a doctor before use.

Other information

OTHER SAFETY INFORMATION

Store below 77 ºF (25 ºC)

Do not use if tamper evident seal around bottle neck is missing or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin [vegetable], purified water

Questions

OTC - QUESTIONS SECTION

800-319-9151 8am-5pm (EST) Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bach Original Flower Remedies Rock RoseBach Original Flower Remedies Rock Rose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-225-10Bach Original Flower Remedies Rock Rose10 mL in 1 BOTTLE, DROPPERSOLUTION101
57687-225-10Bach Original Flower Remedies Rock Rose1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-225BACH ORIGINAL FLOWER REMEDIES ROCK ROSE (HELIANTHEMUM NUMMULARIUM) SOLUTION [NELSON BACH USA LIMITED]1Current NDC, Legacy NDC, 2 package rows20221004_ea240330-bb54-4970-e053-2a95a90aef97.zip

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
57687-22557687-225-10

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
GLYCERINPDC6A3C0OXIACT
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
WATER059QF0KO0RIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bach Fear No More Bravery KitASPEN, CHERRY PLUM, ROCK ROSENelson Bach USA Limited066bc3ce-69ce-fba8-e063-6394a90ac4632023-10-17WarningsExact identifier
ndc (package): 57687-225-10
ndc11 (package): 57687022510
Bach Original Flower Remedies Rock RoseHELIANTHEMUM NUMMULARIUMNelson Bach USA Limitedea240330-bb54-4970-e053-2a95a90aef972022-10-03WarningsExact identifier
ndc (package): 57687-225-10
ndc (product): 57687-225
ndc11 (package): 57687022510
spl id: ea240330-bb55-4970-e053-2a95a90aef97
spl set id: ea240330-bb54-4970-e053-2a95a90aef97

Reported adverse events (FAERS/openFDA)#

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