FDA.reportPublic FDA data

ThroatSpray

Product NDC
44911-0737
11-digit product format
449110737
Labeler code
44911
Product ID
44911-0737_490e2979-4bbb-4cae-9b78-5fd96ca2405c
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
SPRAY
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-04-29
Substance
ACMELLA OLERACEA FLOWERING TOP; APIS MELLIFERA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; CLOVE; ECHINACEA ANGUSTIFOLIA WHOLE; GLYCERIN; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; MYRRH; PHYTOLACCA AMERICANA ROOT; SAGE; THYMUS SERPYLLUM WHOLE
Active strength
2; 12; 12; 3; 15; 1; 1; 1; 6; 12; 12; 2; 4; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ThroatSpray
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA ANGUSTIFOLIA WHOLE2 [hp_X]/mL
CLOVE12 [hp_X]/mL
GLYCERIN12 [hp_X]/mL
MYRRH3 [hp_X]/mL
SAGE15 [hp_X]/mL
ACMELLA OLERACEA FLOWERING TOP1 [hp_X]/mL
THYMUS SERPYLLUM WHOLE1 [hp_X]/mL
BAPTISIA TINCTORIA ROOT1 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/mL
GOLDENSEAL12 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
ATROPA BELLADONNA2 [hp_X]/mL
LACHESIS MUTA VENOM4 [hp_X]/mL
MERCURIUS SOLUBILIS2 [hp_X]/mL
CALCIUM SULFIDE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VB06AV5US8Internal UNII lookup
K48IKT5321Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
JC71GJ1F3LInternal UNII lookup
065C5D077JInternal UNII lookup
1O11RD9U53Internal UNII lookup
86H4S6K51NInternal UNII lookup
5EF0HWI5WUInternal UNII lookup
11E6VI8VEGInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
7S82P3R43ZInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
VSW71SS07IInternal UNII lookup
324Y4038G2Internal UNII lookup
1MBW07J51QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125ffbf4-681e-451c-a96d-0b6416619474Available on FDA.report

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

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 (product): 44911-0737

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44911-0737-14491107370160 mL in 1 BOTTLE, SPRAY (44911-0737-1) 60 ml2025-04-29NoNoCurrent