FDA.reportPublic FDA data

Back Ache Drops

Manufacturer
BioEnergetics, Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:50:08

Label at a glance#

ProductBack Ache
Active ingredientBERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, LYTTA VESICATORIA, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Berberis vulg 6x,

Bryonia alba 6x,

Cantharis 6x,

Rhododendron chr 8x,

Solidago vigr 6x.

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

For relief from pain and discomfort of back ache

These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

Dosage:

DOSAGE & ADMINISTRATION SECTION

In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes.  Children, one half the above dosage. For children 2 years and under, and for people nursing a baby or pregnant, seek the advice of a health professional before use.

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

IF BioE IMPRINTED SEAL ON NECK IS BROKEN

OTC - STOP USE SECTION

If symptoms worsen or persist for more than 7 days, consult a physician.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back Ache DropsBack Ache Drops

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-441457293-4414-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
RHODODENDRON AUREUM LEAFIV92NQJ73UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB

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
d350259d-862d-559b-e053-2a95a90a7ebf02f92be2-98a9-4bc4-89e9-6f1b665e7b8d2021-12-16WarningsExact identifier
spl set id: 02f92be2-98a9-4bc4-89e9-6f1b665e7b8d

Reported adverse events (FAERS/openFDA)#

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