Home NDC 61077-005 H-BI Hemorrhoids Formula
Product NDC 61077-005
11-digit product format 610770005
Labeler code 61077
Product ID 61077-005_b6a0fff6-0ded-49d8-be48-a2a2d17bcd53
Type HUMAN OTC DRUG
Nonproprietary name calendula officinallis, hamamelis virginiana
Dosage form OIL
Route TOPICAL
Labeler Healing Natural Oils LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-11-06
Substance CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
Active strength 12; 6 [hp_C]/11mL; [hp_C]/11mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-BI Hemorrhoids Formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_C]/11mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 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 18E7415PXQ Internal UNII lookup T7S323PKJS 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 61077-005-11 H-BI Hemorrhoids Formula 11 mL in 1 BOTTLE, DROPPER OIL 11 2 61077-005-33 H-BI Hemorrhoids Formula 33 mL in 1 BOTTLE, DROPPER OIL 33 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALENDULA OFFICINALIS FLOWERING TOP ACTIVE INGREDIENT 18E7415PXQ H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ACTIVE INGREDIENT T7S323PKJS H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 CALENDULA OFFICINALIS FLOWERING TOP ACTIVE MOIETY 18E7415PXQ H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ACTIVE MOIETY T7S323PKJS H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 EUROPEAN HAZELNUT OIL INACTIVE INGREDIENT 8RQ2839AVG H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 HELICHRYSUM ITALICUM FLOWER INACTIVE INGREDIENT P62Y550X24 H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1 PELARGONIUM GRAVEOLENS WHOLE INACTIVE INGREDIENT 0E553RP62F H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61077-005 H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20171211_a6f59c34-e252-4458-8ce4-01e2d3028aa8.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 61077-005-11 61077000511 11 mL in 1 BOTTLE, DROPPER (61077-005-11) 11 ml 2013-11-06 0000-00-00 No No Current 61077-005-33 61077000533 33 mL in 1 BOTTLE, DROPPER (61077-005-33) 33 ml 2013-11-06 0000-00-00 No No Current