Arnica Gel 15

Product NDC: 80004-400
11-digit product format: 800040400
Labeler code: 80004
Product ID: 80004-400_4e5703a4-8d42-cd94-e063-6294a90a5a89
Type: HUMAN OTC DRUG
Nonproprietary name: Arnica Gel
Dosage form: GEL
Route: TOPICAL
Labeler: VITAMEDICA, INC.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2024-03-01
Substance: ACHILLEA MILLEFOLIUM FLOWER; ARNICA MONTANA FLOWER; ARNICA MONTANA WHOLE; BELLADONNA LEAF; BELLIS PERENNIS FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE WHOLE; RHUS TYPHINA WHOLE; RUTA GRAVEOLENS WHOLE; SYMPHYTUM OFFICINALE WHOLE
Active strength: 12; 1; 30; 30; 12; 1; 1; 1; 12; 30; 30; 6 [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Arnica Gel 15
Brand name suffix: Arnica Montana 1X HPUS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYPERICUM PERFORATUM	12 [hp_X]/g
SYMPHYTUM OFFICINALE WHOLE	1 [hp_X]/g
ARNICA MONTANA WHOLE	30 [hp_C]/g
RHUS TYPHINA WHOLE	30 [hp_X]/g
HAMAMELIS VIRGINIANA BARK	12 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]/g
ARNICA MONTANA FLOWER	1 [hp_X]/g
LEDUM PALUSTRE WHOLE	1 [hp_X]/g
ACHILLEA MILLEFOLIUM FLOWER	12 [hp_X]/g
BELLADONNA LEAF	30 [hp_X]/g
BELLIS PERENNIS FLOWER	30 [hp_X]/g
RUTA GRAVEOLENS WHOLE	6 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XK4IUX8MNB	Internal UNII lookup
H8FJJ6KX5Y	Internal UNII lookup
O80TY208ZW	Internal UNII lookup
Y465D8AABT	Internal UNII lookup
IH3063S9MY	Internal UNII lookup
18E7415PXQ	Internal UNII lookup
OZ0E5Y15PZ	Internal UNII lookup
1N8KG72C5M	Internal UNII lookup
YQR8R0SQEA	Internal UNII lookup
6GZW20TIOI	Internal UNII lookup
26I94X9A1K	Internal UNII lookup
181JI0338P	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
4e56ff37-e260-be18-e063-6294a90aaced	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80004-400-40	Arnica Gel 15Arnica Montana 1X HPUS	85 g in 1 TUBE	GEL	85		1
80004-400-40	Arnica Gel 15Arnica Montana 1X HPUS	1 in 1 CARTON	GEL	1		1

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
Arnica Gel 15 Arnica Montana 1X HPUS	ARNICA GEL	VITAMEDICA, INC.	4e56ff37-e260-be18-e063-6294a90aaced	2024-03-31	Warnings	Exact identifier ndc (product): 80004-400

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
YQR8R0SQEA	ACHILLEA MILLEFOLIUM FLOWER	ACHILLEA MILLEFOLIUM FLOWER
OZ0E5Y15PZ	ARNICA MONTANA FLOWER	ARNICA MONTANA FLOWER
6GZW20TIOI	BELLADONNA LEAF	BELLADONNA LEAF
26I94X9A1K	BELLIS PERENNIS FLOWER	BELLIS PERENNIS FLOWER
18E7415PXQ	CALENDULA OFFICINALIS FLOWERING TOP	CALENDULA OFFICINALIS FLOWERING TOP
IH3063S9MY	HAMAMELIS VIRGINIANA BARK	HAMAMELIS VIRGINIANA BARK
XK4IUX8MNB	HYPERICUM PERFORATUM	HYPERICUM PERFORATUM
Y465D8AABT	RHUS TYPHINA WHOLE	RHUS TYPHINA WHOLE
181JI0338P	RUTA GRAVEOLENS WHOLE	RUTA GRAVEOLENS WHOLE
H8FJJ6KX5Y	SYMPHYTUM OFFICINALE WHOLE	SYMPHYTUM OFFICINALE WHOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80004-400-40	80004040040	1 TUBE in 1 CARTON (80004-400-40) / 85 g in 1 TUBE	1 tube	2024-03-01	No	No	Current