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
IngredientStrength
ACHILLEA MILLEFOLIUM FLOWER12 [hp_X]/g
ARNICA MONTANA FLOWER1 [hp_X]/g
ARNICA MONTANA WHOLE30 [hp_C]/g
BELLADONNA LEAF30 [hp_X]/g
BELLIS PERENNIS FLOWER12 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/g
HAMAMELIS VIRGINIANA BARK1 [hp_X]/g
HYPERICUM PERFORATUM1 [hp_X]/g
LEDUM PALUSTRE WHOLE12 [hp_X]/g
RHUS TYPHINA WHOLE30 [hp_X]/g
RUTA GRAVEOLENS WHOLE30 [hp_X]/g
SYMPHYTUM OFFICINALE WHOLE6 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQR8R0SQEA, OZ0E5Y15PZ, O80TY208ZW, 6GZW20TIOI, 26I94X9A1K, 18E7415PXQ, IH3063S9MY, XK4IUX8MNB, 1N8KG72C5M, Y465D8AABT, 181JI0338P, H8FJJ6KX5Y

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS85 g in 1 TUBEGEL851
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS1 in 1 CARTONGEL11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80004-400-40800040400401 TUBE in 1 CARTON (80004-400-40) / 85 g in 1 TUBE1 tube2024-03-01NoNoCurrent