FDA.reportPublic FDA data

Flutone

Product NDC
44911-0514
11-digit product format
449110514
Labeler code
44911
Product ID
44911-0514_cf71dcb5-9fbc-4a0f-abbf-a76fd866754b
Type
HUMAN OTC DRUG
Nonproprietary name
Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Arsenicum Album, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ipecacuanha, Rhus Tox.
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-09
Substance
ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; IPECAC; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 3; 12; 3; 12; 12; 12; 6; 12; 4; 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; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BAPTISIA TINCTORIA ROOT12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT12 [hp_X]/mL
GOLDENSEAL3 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP12 [hp_X]/mL
FERROSOFERRIC PHOSPHATE6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]/mL
IPECAC4 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5EF0HWI5WU, VB06AV5US8, 11E6VI8VEG, ZW3Z11D0JV, S7V92P67HO, T7J046YI2B, 1W0775VX6E, 91GQH8I5F7, 639KR60Q1Q, 62I3C8233L, 6IO182RP7A

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
44911-0514-12024-03-26C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12023-01-30C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12021-12-22C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12021-01-29C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0514-1Flutone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0514FLUTONE (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240328_d5359dc3-e0b9-421b-9ee6-7e38e1002f00.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0514-14491105140130 mL in 1 BOTTLE, DROPPER (44911-0514-1) 30 ml2019-10-090000-00-00NoNoCurrent