Salsolinol

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2018-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:33

Label at a glance#

ProductSalsolinol
Active ingredientSALSOLINOL HYDROCHLORIDE, (+/-)-
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Salsolinol (Hydrochloride) 6X, 12X, 30X, 12C, 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of elbow pain, headaches, craving for chocolate, confusion, sinus pressure and weakness.

WARNINGS:

WARNINGS SECTION

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of elbow pain, headaches, craving for chocolate, confusion, sinus pressure and weakness.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional
SALSOLINOL
HOMEOPATHIC
1 FL OZ (30 ml)

SalsolinolSalsolinol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0501-1Salsolinol30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0501SALSOLINOL (SALSOLINOL (HYDROCHLORIDE)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20181208_937ff58f-27f0-448a-9da7-910a54d98f54.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
43857-050143857-0501-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
SalsolinolSALSOLINOL (HYDROCHLORIDE)BioActive Nutritional, Inc.937ff58f-27f0-448a-9da7-910a54d98f542018-12-07WarningsExact identifier
ndc (package): 43857-0501-1
ndc (product): 43857-0501
ndc11 (package): 43857050101
spl id: 642aeb8b-bbf2-4fed-9a4b-0fe9562961a9
spl set id: 937ff58f-27f0-448a-9da7-910a54d98f54

Reported adverse events (FAERS/openFDA)#

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