FDA.reportPublic FDA data

Lab1796 Sore Throat Soothe

Manufacturer
HomeopathyStore.com
Effective date
2010-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:45

Label at a glance#

ProductLab1796 Sore Throat Soothe
Active ingredientACONITUM NAPELLUS, APIS MELLIFERA, ATROPA BELLADONNA, SOLANUM DULCAMARA TOP, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT
Label structure6 sections

Indications and uses

For the temporary relief of symptoms associated with sore throat, loss of voice, and laryngitis.

Dosage and administration

Dissolve 3-5 pellets directly in mouth 3 times a day or as needed. Children under 12 use half of adult dose or as directed by doctor.

Label contents#

Full prescribing information#

Uses:

OTC - PURPOSE SECTION

For the temporary relief of symptoms associated with sore throat, loss of voice, and laryngitis.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

(HPUS) Aconitum nap. 10X, Apis mellifica 10X, Belladonna 10X, Dulcamara 8X , Mercurius sol. 10X, Phytolacca decandra 8X

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sucrose/lactose

Directions:

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

Dissolve 3-5 pellets directly in mouth 3 times a day or as needed. Children under 12 use half of adult dose or as directed by doctor.

Warnings:

WARNINGS SECTION

Consult doctor if symptoms persist or worsen; pregnant or nursing; patient is under 3 years of age; sore throat persists for more than 2 days or occurs with high fever, headache, nausea, or vomiting. Do not use if cap seal is broken.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59875-1015-12020-01-31C16284748780-19d75b9d0-5ce6-f424-e053-dadaa90a57ceSore Throat Soothe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59875-1015-1Lab1796 Sore Throat Soothe85 in 1 TUBEPELLET851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59875-1015LAB1796 SORE THROAT SOOTHE (ACONITUM NAPELLUS, APIS MELLIFERA, ATROPA BELLADONNA, SOLANUM DULCAMARA TOP, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT) PELLET [HOMEOPATHYSTORE.COM]1Legacy NDC, 1 package rows20110104_c7fadff0-1ec5-4a16-ac6d-29cc80d8f446.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162N1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162N1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
SUCROSEINACTIVE INGREDIENTC151H8M5541

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59875-101559875-1015-1
61727-311

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii+route

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
Sore Throat ReliefACONITUM NAPELLUS,APIS MELLIFERA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,MERCURIUS SOLUBILIS,PHYTOLACCA AMERICANA ROOT.Homeocare Laboratoriesf8a65318-eb0f-48b4-9578-c7a6cf799bc12018-12-26WarningsExact identifier
ndc (product): 61727-311
8d8f2b97-8138-49b0-87e3-c84801f2dc6cc7fadff0-1ec5-4a16-ac6d-29cc80d8f4462010-12-29WarningsExact identifier
spl id: 8d8f2b97-8138-49b0-87e3-c84801f2dc6c
spl set id: c7fadff0-1ec5-4a16-ac6d-29cc80d8f446

Reported adverse events (FAERS/openFDA)#

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