Breast Care

Product NDC
55714-2394
11-digit product format
557142394
Labeler code
55714
Product ID
55714-2394_b4df8965-99b3-4349-e053-2a95a90a5e3c
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
2018-11-05
Substance
BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; 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; PULSATILLA VULGARIS; 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55714-239455714-2394-0DDiscontinued by firm2026-09-14
excluded packagepackage55714-239455714-2394-2DDiscontinued by firm2026-09-14

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55714-2394-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55714-2394-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55714-2394-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55714-2394-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55714-2394-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55714-2394-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55714-2394-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55714-2394-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55714-2394-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55714-2394-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55714-2394-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55714-2394-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2394-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2394-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2394-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2394-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2394-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2394-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2394-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2394-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55714-2394-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55714-2394-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55714-2394-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55714-2394-0DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55714-2394-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55714-2394-0DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUFO BUFO CUTANEOUS GLAND15 [hp_X]/mL
APIS MELLIFERA15 [hp_X]/mL
ASTERIAS RUBENS15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
MATRICARIA RECUTITA15 [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
CHAMAELIRIUM LUTEUM ROOT15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
MERCURY15 [hp_X]/mL
OENANTHE AQUATICA FRUIT15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q59QU6N72QInternal UNII lookup
7S82P3R43ZInternal UNII lookup
A7FYY9Q742Internal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
2E32821G6IInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
WCK21A9W9JInternal UNII lookup
S003A158SBInternal UNII lookup
Q28R5GF371Internal UNII lookup
0HK2GZK66EInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
4QQN74LH4OInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
VSW71SS07IInternal UNII lookup
FXS1BY2PGLInternal UNII lookup
N4LEE4Z93JInternal UNII lookup
27YLU75U4WInternal UNII lookup
11E6VI8VEGInternal UNII lookup
I76KB35JEVInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79edde91-f909-f7b3-e053-2991aa0a9d1cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2394-0Breast Care15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2394-1Breast Care30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2394-2Breast Care50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2394BREAST CARE (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, 3 package rows20201125_79edde91-f909-f7b3-e053-2991aa0a9d1c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Breast CareBUFO 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, TARAXACUMNewton Laboratories, Inc.79edde91-f909-f7b3-e053-2991aa0a9d1c2020-11-24WarningsExact identifier
ndc (product): 55714-2394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2394-05571423940015 mL in 1 BOTTLE, GLASS15 mlHistorical
55714-2394-15571423940130 mL in 1 BOTTLE, GLASS (55714-2394-1) 30 ml2018-11-050000-00-00NoNoCurrent
55714-2394-25571423940250 mL in 1 BOTTLE, GLASS50 mlHistorical