Home NDC 55714-4828 Breast Care - Fibrocystic
Product NDC 55714-4828
11-digit product format 557144828
Labeler code 55714
Product ID 55714-4828_b5804ae4-1b82-3f5f-e053-2a95a90a440d
Type HUMAN OTC DRUG
Nonproprietary name Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum
Dosage form LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2018-09-02
Substance BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; LACHESIS MUTA VENOM; MERCURY; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE
Active strength 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-4828-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-4828-1 0efc9e666f02…f202fb6c5f17…
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 Care - Fibrocystic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUFO BUFO CUTANEOUS GLAND 15 [hp_X]/mL APIS MELLIFERA 15 [hp_X]/mL ASTERIAS RUBENS 15 [hp_X]/mL ATROPA BELLADONNA 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X]/mL MATRICARIA CHAMOMILLA 15 [hp_X]/mL CHIMAPHILA UMBELLATA 15 [hp_X]/mL CINCHONA OFFICINALIS BARK 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL CROTON TIGLIUM SEED 15 [hp_X]/mL ECHINACEA, UNSPECIFIED 15 [hp_X]/mL GRAPHITE 15 [hp_X]/mL CHAMAELIRIUM LUTEUM ROOT 15 [hp_X]/mL LACHESIS MUTA VENOM 15 [hp_X]/mL MERCURY 15 [hp_X]/mL OENANTHE AQUATICA FRUIT 15 [hp_X]/mL PHOSPHORUS 15 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 15 [hp_X]/mL ANEMONE PULSATILLA 15 [hp_X]/mL SANGUINARIA CANADENSIS ROOT 15 [hp_X]/mL SILICON DIOXIDE 15 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/mL TARAXACUM OFFICINALE 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 25 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 55714-4828-1 Breast Care - Fibrocystic 30 mL in 1 BOTTLE, GLASS LIQUID 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-4828 BREAST CARE - FIBROCYSTIC (BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20201203_98d01128-9887-12ce-e053-2a95a90a7329.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Breast Care - Fibrocystic BUFO RANA, APIS MEL., ASTERIAS RUBENS, BELLADONNA, BRYONIA, CALC. CARB., CHAMOMILLA, CHIMAPHILA UMBELLATA, CINCHONA, CONIUM, CROTON, ECHINACEA, GRAPHITES, HELONIAS DIOICA, LACHESIS, MERC. VIV., PHELLANDRIUM AQUATICUM PHOSPHORUS, PHYTOLACCA, PULSATILLA, SANGUINARIA, SILICEA, HAMAMELIS, RUTA, TARAXACUM Newton Laboratories, Inc. 98d01128-9887-12ce-e053-2a95a90a7329 2020-12-02 Warnings Exact identifier ndc (product): 55714-4828
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-4828-1 55714482801 30 mL in 1 BOTTLE, GLASS (55714-4828-1) 30 ml 2019-09-02 0000-00-00 No No Current