FDA.reportPublic FDA data

ThroatSpray

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:33:28

Label at a glance#

ProductThroatSpray
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, CLOVE, GLYCERIN, MYRRH, SAGE, ACMELLA OLERACEA FLOWERING TOP, THYMUS SERPYLLUM WHOLE, BAPTISIA TINCTORIA ROOT, PHYTOLACCA AMERICANA ROOT, GOLDENSEAL, APIS MELLIFERA, ATROPA BELLADONNA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, CALCIUM SULFIDE
Label structure9 sections

Dosage and administration

Adults and children spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray): 6.67% of Apis Mellifica 12X, Baptisia Tinctoria 3X, Belladonna 12X, Echinacea 1X, Eugenia Caryophyllata 1X, Glycerinum 1X, Hepar Sulphuris Calcareum 15X, Hydrastis Canadensis 6X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Myrrha 2X, Phytolacca Decandra 4X, Salvia Officinalis 2X, Spilanthes Oleracea 2X, Thymus Serpyllum 2X.

PURPOSE:

OTC - PURPOSE SECTION

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, ask a health 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 a cool, dry place.

Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children spray orally 4-6 times daily or as otherwise directed by a health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve swollen sensation, minor throat pain, and burning of the throat.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol, Glycerin.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

THROAT SPRAY

2 fl. oz. (60 ml)

THROAT SPRAYTHROAT SPRAY

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0737-1ThroatSpray60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0737THROATSPRAY (ECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUM) SPRAY [ENERGIQUE, INC.]1Current NDC, 1 package rows20250430_125ffbf4-681e-451c-a96d-0b6416619474.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-073744911-0737-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
CLOVEK48IKT5321ACTIB
GLYCERINPDC6A3C0OXACTIB
MYRRHJC71GJ1F3LACTIB
SAGE065C5D077JACTIB
ACMELLA OLERACEA FLOWERING TOP1O11RD9U53ACTIB
THYMUS SERPYLLUM WHOLE86H4S6K51NACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
GOLDENSEALZW3Z11D0JVACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
ndc (package): 44911-0737-1
ndc (product): 44911-0737
ndc11 (package): 44911073701
spl id: 490e2979-4bbb-4cae-9b78-5fd96ca2405c
spl set id: 125ffbf4-681e-451c-a96d-0b6416619474

Reported adverse events (FAERS/openFDA)#

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