DERMATOME STAT

Product NDC: 44911-0570
Requested package NDC: 44911-0570-1
11-digit product format: 449110570
Labeler code: 44911
Product ID: 44911-0570_4bc06485-b85c-4da9-bc84-abf77bc23f18
Type: HUMAN OTC DRUG
Nonproprietary name: Astragalus Membranaceus, Echinacea (Angustifolia), Hypericum Perforatum, Hydrastis Canadensis, Dulcamara, Gelsemium Sempervirens, Nitricum Acidum, Ranunculus Bulbosus, Thuja Occidentalis
Dosage form: LIQUID
Route: ORAL
Labeler: Energique, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2021-05-24
Substance: ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; HYPERICUM PERFORATUM WHOLE; GOLDENSEAL; SOLANUM DULCAMARA TOP; GELSEMIUM SEMPERVIRENS ROOT; NITRIC ACID; RANUNCULUS BULBOSUS WHOLE; THUJA OCCIDENTALIS LEAFY TWIG
Active strength: 3; 3; 3; 6; 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
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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: DERMATOME STAT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASTRAGALUS PROPINQUUS ROOT	3 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE	3 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE	3 [hp_X]/mL
GOLDENSEAL	6 [hp_X]/mL
SOLANUM DULCAMARA TOP	12 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]/mL
NITRIC ACID	12 [hp_X]/mL
RANUNCULUS BULBOSUS WHOLE	12 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
922OP8YUPF	Internal UNII lookup
VB06AV5US8	Internal UNII lookup
XK4IUX8MNB	Internal UNII lookup
ZW3Z11D0JV	Internal UNII lookup
KPS1B1162N	Internal UNII lookup
639KR60Q1Q	Internal UNII lookup
411VRN1TV4	Internal UNII lookup
AEQ8NXJ0MB	Internal UNII lookup
1NT28V9397	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
6e48c2a9-f08a-418f-9b25-03a2010c340f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44911-0570-1	2024-08-20	C162847	48780-1	f386c64a-0417-0266-e053-dadaa90a7c1a	DRUG FACTS:
44911-0570-1	2023-01-30	C162847	48780-1	f386c64a-0417-0266-e053-dadaa90a7c1a	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44911-0570-1	DERMATOME STAT	30 mL in 1 BOTTLE, DROPPER	LIQUID	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44911-0570	DERMATOME STAT (ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, DULCAMARA, GELSEMIUM SEMPERVIRENS, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240822_6e48c2a9-f08a-418f-9b25-03a2010c340f.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
DERMATOME STAT	ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, DULCAMARA, GELSEMIUM SEMPERVIRENS, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, THUJA OCCIDENTALIS	Energique, Inc.	6e48c2a9-f08a-418f-9b25-03a2010c340f	2024-08-20	Warnings	Exact identifier ndc (package): 44911-0570-1 ndc (product): 44911-0570 ndc11 (package): 44911057001

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
922OP8YUPF	ASTRAGALUS PROPINQUUS ROOT		ASTRAGALUS PROPINQUUS ROOT
ZW3Z11D0JV	GOLDENSEAL		GOLDENSEAL
KPS1B1162N	SOLANUM DULCAMARA TOP		SOLANUM DULCAMARA TOP
639KR60Q1Q	GELSEMIUM SEMPERVIRENS ROOT		GELSEMIUM SEMPERVIRENS ROOT
411VRN1TV4	NITRIC ACID	7697-37-2	NITRIC ACID
1NT28V9397	THUJA OCCIDENTALIS LEAFY TWIG		THUJA OCCIDENTALIS LEAFY TWIG

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44911-0570-1	44911057001	30 mL in 1 BOTTLE, DROPPER (44911-0570-1)	30 ml	2021-05-24	0000-00-00	No	No	Current