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
ANEMONE PULSATILLA; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CHAMAELIRIUM LUTEUM ROOT; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA; MERCURY; OENANTHE AQUATICA FRUIT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Breast Care - Fibrocystic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANEMONE PULSATILLA15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
ASTERIAS RUBENS15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
BUFO BUFO CUTANEOUS GLAND15 [hp_X]/mL
CHAMAELIRIUM LUTEUM ROOT15 [hp_X]/mL
CHIMAPHILA UMBELLATA15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
CROTON TIGLIUM SEED15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
MATRICARIA CHAMOMILLA15 [hp_X]/mL
MERCURY15 [hp_X]/mL
OENANTHE AQUATICA FRUIT15 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, 7S82P3R43Z, A7FYY9Q742, WQZ3G9PF0H, T7J046YI2B, Q59QU6N72Q, DQV54Y5H3U, WCK21A9W9J, S003A158SB, Q28R5GF371, 0HK2GZK66E, 4N9P6CC1DX, 4QQN74LH4O, T7S323PKJS, VSW71SS07I, G0R4UBI2ZZ, FXS1BY2PGL, N4LEE4Z93J, 2E32821G6I, 27YLU75U4W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4828-1Breast Care - Fibrocystic30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4828BREAST 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.]3Current NDC, Legacy NDC, 1 package rows20201203_98d01128-9887-12ce-e053-2a95a90a7329.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4828-15571448280130 mL in 1 BOTTLE, GLASS (55714-4828-1) 30 ml2019-09-020000-00-00NoNoCurrent