ThroatSpray

Product NDC
44911-0450
11-digit product format
449110450
Labeler code
44911
Product ID
44911-0450_e6ae5054-2fad-4693-bf37-b592cd051c69
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
2018-03-13
Marketing end
2028-10-03
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; 2 [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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ThroatSpray

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACMELLA OLERACEA FLOWERING TOP2 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
ATROPA BELLADONNA12 [hp_X]/mL
BAPTISIA TINCTORIA ROOT3 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CLOVE1 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE1 [hp_X]/mL
GLYCERIN1 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
LACHESIS MUTA VENOM12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
MYRRH2 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT4 [hp_X]/mL
SAGE2 [hp_X]/mL
THYMUS SERPYLLUM WHOLE2 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1O11RD9U53, 7S82P3R43Z, WQZ3G9PF0H, 5EF0HWI5WU, 1MBW07J51Q, K48IKT5321, VB06AV5US8, PDC6A3C0OX, ZW3Z11D0JV, VSW71SS07I, 324Y4038G2, JC71GJ1F3L, 11E6VI8VEG, 065C5D077J, 86H4S6K51N

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0450-12024-10-30C16284748780-11030e365-5b27-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0450-12024-01-30C16284748780-11030e365-5b27-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0450-1ThroatSpray60 mL in 1 BOTTLE, SPRAYSPRAY604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0450THROATSPRAY (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.]4Current NDC, Legacy NDC, 1 package rows20250519_3c4c3e7f-0ef9-4de0-b0bf-97fe7f6a527c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0450-14491104500160 mL in 1 BOTTLE, SPRAY (44911-0450-1) 60 ml2018-03-132028-10-03NoNoCurrent