Home NDC 61077-135-11 H-Gout Formula
Product NDC 61077-135
Requested package NDC 61077-135-11
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 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61077-135 61077-135-11 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 H-Gout Formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARNICA MONTANA 12 [hp_C]/11mL RHODODENDRON AUREUM LEAF 6 [hp_C]/11mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O80TY208ZW Internal UNII lookup IV92NQJ73U Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61077-135-11 H-Gout Formula 11 mL in 1 BOTTLE, DROPPER OIL 11 3 61077-135-33 H-Gout Formula 33 mL in 1 BOTTLE, DROPPER OIL 33 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61077-135 H-GOUT FORMULA (ARNICA MONTANA, RHODODENDRON) OIL [HEALING NATURAL OILS LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241213_10b7b1ed-e5d4-4157-a7f7-65a8b2876245.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61077-135-11 61077013511 11 mL in 1 BOTTLE, DROPPER (61077-135-11) 11 ml 2014-10-29 0000-00-00 No No Current