FDA.reportPublic FDA data

H-Gout Formula

Product NDC
61077-135
11-digit product format
610770135
Labeler code
61077
Product ID
61077-135_2906c142-d151-b339-e063-6294a90a4b76
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Rhododendron
Dosage form
OIL
Route
TOPICAL
Labeler
Healing Natural Oils LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-10-29
Substance
ARNICA MONTANA; RHODODENDRON AUREUM LEAF
Active strength
12; 6 [hp_C]/11mL; [hp_C]/11mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
H-Gout Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA12 [hp_C]/11mL
RHODODENDRON AUREUM LEAF6 [hp_C]/11mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, IV92NQJ73U

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-135-11H-Gout Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-135-33H-Gout Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-135H-GOUT FORMULA (ARNICA MONTANA, RHODODENDRON) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20241213_10b7b1ed-e5d4-4157-a7f7-65a8b2876245.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61077-135-116107701351111 mL in 1 BOTTLE, DROPPER (61077-135-11) 11 ml2014-10-290000-00-00NoNoCurrent
61077-135-336107701353333 mL in 1 BOTTLE, DROPPER (61077-135-33) 33 ml2014-10-290000-00-00NoNoCurrent