FDA.reportPublic FDA data

Sinutone

Product NDC
44911-0515
11-digit product format
449110515
Labeler code
44911
Product ID
44911-0515_7b96bbe1-f255-4bff-aaeb-4e00b4777be4
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea (Angustifolia), Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata, Pulsatilla (Pratensis), Sepia, Solidago Virgaurea
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-09
Substance
AMBROSIA ARTEMISIIFOLIA WHOLE; ARSENIC TRIOXIDE; ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; NUTMEG; ONION; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
12; 12; 3; 6; 12; 12; 12; 12; 12; 12 [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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBROSIA ARTEMISIIFOLIA WHOLE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
GOLDENSEAL6 [hp_X]/mL
NUTMEG12 [hp_X]/mL
ONION12 [hp_X]/mL
POTASSIUM DICHROMATE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9W34L2CQ9A, S7V92P67HO, VB06AV5US8, ZW3Z11D0JV, AEE24M3MQ9, 492225Q21H, T4423S18FM, 8E272251DI, QDL83WN8C2, 5405K23S50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0515-12024-04-19C16284748780-1ba0f9c33-5bda-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0515-12023-01-30C16284748780-1ba0f9c33-5bda-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0515-12021-10-19C16284748780-1ba0f9c33-5bda-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0515-12021-01-29C16284748780-1ba0f9c33-5bda-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0515-1Sinutone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0515SINUTONE (ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, KALI BICHROMICUM, NUX MOSCHATA, PULSATILLA (PRATENSIS), SEPIA, SOLIDAGO VIRGAUREA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240420_7333663c-a79d-44d2-93ac-a9254c2b32c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0515-14491105150130 mL in 1 BOTTLE, DROPPER (44911-0515-1) 30 ml2019-10-090000-00-00NoNoCurrent