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
ANGELICA SINENSIS ROOT; BLACK PEPPER; CITRUS MEDICA VAR. SARCODACTYLIS WHOLE; CRATAEGUS RIVULARIS WHOLE; CURCUMA AROMATICA ROOT; PRUNUS PERSICA SEED; ROSA RUGOSA FLOWER; TANGERINE PEEL; TARAXACUM OFFICINALE
Active strength
30; 2; 30; 30; 510; 30; 70; 30; 90 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

Additional Listing Data#

Finished product
Yes
Brand name base
BREAST NODULE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGELICA SINENSIS ROOT30 mg/g
BLACK PEPPER2 mg/g
CITRUS MEDICA VAR. SARCODACTYLIS WHOLE30 mg/g
CRATAEGUS RIVULARIS WHOLE30 mg/g
CURCUMA AROMATICA ROOT510 mg/g
PRUNUS PERSICA SEED30 mg/g
ROSA RUGOSA FLOWER70 mg/g
TANGERINE PEEL30 mg/g
TARAXACUM OFFICINALE90 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB66F4574UG, KM66971LVF, W34IF71M2W, WLL8F7NDKG, C7X957O5YS, V9C81470RR, 969IQC5YJU, JU3D414057, 39981FM375

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85631-010-01BREAST NODULE60 in 1 BOTTLECAPSULE601
85631-010-01BREAST NODULE1 g in 1 CAPSULECAPSULE11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85631-010-018563100100160 CAPSULE in 1 BOTTLE (85631-010-01) / 1 g in 1 CAPSULE60 capsule2025-11-03NoNoCurrent