Home NDC 85631-010 BREAST NODULE
Product NDC 85631-010
11-digit product format 856310010
Labeler code 85631
Product ID 85631-010_42ad5c57-9493-7742-e063-6394a90a6010
Type HUMAN OTC DRUG
Nonproprietary name BREAST NODULE
Dosage form CAPSULE
Route ORAL
Labeler Bispit Canada Ltd.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2025-11-03
Substance CITRUS MEDICA VAR. SARCODACTYLIS WHOLE; BLACK PEPPER; ROSA RUGOSA FLOWER; PRUNUS PERSICA SEED; TANGERINE PEEL; CRATAEGUS RIVULARIS WHOLE; TARAXACUM OFFICINALE; CURCUMA AROMATICA ROOT; ANGELICA SINENSIS ROOT
Active strength 30; 2; 70; 30; 30; 30; 90; 510; 30 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
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 BREAST NODULE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRUS MEDICA VAR. SARCODACTYLIS WHOLE 30 mg/g BLACK PEPPER 2 mg/g ROSA RUGOSA FLOWER 70 mg/g PRUNUS PERSICA SEED 30 mg/g TANGERINE PEEL 30 mg/g CRATAEGUS RIVULARIS WHOLE 30 mg/g TARAXACUM OFFICINALE 90 mg/g CURCUMA AROMATICA ROOT 510 mg/g ANGELICA SINENSIS ROOT 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
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 85631-010-01 BREAST NODULE 60 in 1 BOTTLE CAPSULE 60 1 85631-010-01 BREAST NODULE 1 g in 1 CAPSULE CAPSULE 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85631-010-01 85631001001 60 CAPSULE in 1 BOTTLE (85631-010-01) / 1 g in 1 CAPSULE 60 capsule 2025-11-03 No No Current