Flutone

Product NDC: 44911-0514
Requested package NDC: 44911-0514-1
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: BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; TOXICODENDRON PUBESCENS LEAF
Active strength: 3; 3; 4; 6; 12; 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; [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	44911-0514	44911-0514-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BAPTISIA TINCTORIA ROOT	3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE	3 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT	4 [hp_X]/mL
GOLDENSEAL	6 [hp_X]/mL
ARSENIC TRIOXIDE	12 [hp_X]/mL
BRYONIA ALBA ROOT	12 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP	12 [hp_X]/mL
FERROSOFERRIC PHOSPHATE	12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]/mL
IPECAC	12 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF	12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5EF0HWI5WU	Internal UNII lookup
VB06AV5US8	Internal UNII lookup
11E6VI8VEG	Internal UNII lookup
ZW3Z11D0JV	Internal UNII lookup
S7V92P67HO	Internal UNII lookup
T7J046YI2B	Internal UNII lookup
1W0775VX6E	Internal UNII lookup
91GQH8I5F7	Internal UNII lookup
639KR60Q1Q	Internal UNII lookup
62I3C8233L	Internal UNII lookup
6IO182RP7A	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d5359dc3-e0b9-421b-9ee6-7e38e1002f00	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-03-26	DRUG FACTS:
2023-01-30	DRUG FACTS:
2021-12-22	DRUG FACTS:
2021-01-29	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44911-0514-1	Flutone	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44911-0514	FLUTONE (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.) LIQUID [ENERGIQUE, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240328_d5359dc3-e0b9-421b-9ee6-7e38e1002f00.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flutone	BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.	Energique, Inc.	d5359dc3-e0b9-421b-9ee6-7e38e1002f00	2024-03-26	Warnings	Exact identifier ndc (package): 44911-0514-1 ndc (product): 44911-0514 ndc11 (package): 44911051401

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5EF0HWI5WU	BAPTISIA TINCTORIA ROOT		BAPTISIA TINCTORIA ROOT
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
ZW3Z11D0JV	GOLDENSEAL		GOLDENSEAL
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE
T7J046YI2B	BRYONIA ALBA ROOT		BRYONIA ALBA ROOT
1W0775VX6E	EUPATORIUM PERFOLIATUM FLOWERING TOP		EUPATORIUM PERFOLIATUM FLOWERING TOP
91GQH8I5F7	FERROSOFERRIC PHOSPHATE		FERROSOFERRIC PHOSPHATE
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
62I3C8233L	IPECAC	8012-96-2	IPECAC
6IO182RP7A	TOXICODENDRON PUBESCENS LEAF		TOXICODENDRON PUBESCENS LEAF

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44911-0514-1	44911051401	30 mL in 1 BOTTLE, DROPPER (44911-0514-1)	30 ml	2019-10-09	0000-00-00	No	No	Current