FDA.reportPublic FDA data

Varicose Veins

Product NDC
55714-2553
11-digit product format
557142553
Labeler code
55714
Product ID
55714-2553_498df199-4f65-5032-e063-6394a90a7000
Type
HUMAN OTC DRUG
Nonproprietary name
Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-08-30
Substance
BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SILYBUM MARIANUM SEED; VIPERA BERUS VENOM; ZINC
Active strength
15; 15; 15; 15; 15; 15; 6; 15; 6; 15; 15; 15; 30; 15; 15; 15; 15; 15 [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
NDC exclude flag
No
Listing certified through
2027-12-31
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2553-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2553-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Varicose Veins
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICRURUS CORALLINUS VENOM15 [hp_X]/mL
CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALCIUM FLUORIDE15 [hp_X]/mL
SILYBUM MARIANUM SEED15 [hp_X]/mL
CHOLESTEROL15 [hp_X]/mL
CINCHONA OFFICINALIS BARK6 [hp_X]/mL
DIGITALIS15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/mL
HYDROFLUORIC ACID15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
NAJA NAJA VENOM30 [hp_X]/mL
PULSATILLA VULGARIS15 [hp_X]/mL
VIPERA BERUS VENOM15 [hp_X]/mL
ZINC15 [hp_X]/mL
HORSE CHESTNUT15 [hp_X]/mL
ECHINACEA, UNSPECIFIED15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V0S6H36980Internal UNII lookup
YHA2XLJ956Internal UNII lookup
T7J046YI2BInternal UNII lookup
O3B55K4YKIInternal UNII lookup
U946SH95EEInternal UNII lookup
97C5T2UQ7JInternal UNII lookup
S003A158SBInternal UNII lookup
F1T8QT9U8BInternal UNII lookup
T7S323PKJSInternal UNII lookup
RGL5YE86CZInternal UNII lookup
VSW71SS07IInternal UNII lookup
C88X29Y479Internal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
I76KB35JEVInternal UNII lookup
0ORO6NCA4MInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
3C18L6RJAZInternal UNII lookup
4N9P6CC1DXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91e8e37c-c654-6df9-e053-2995a90aafe1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2553-1Varicose Veins30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2553VARICOSE VEINS (ELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201201_91e8e37c-c654-6df9-e053-2995a90aafe1.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
Varicose VeinsELAPS CORALLINUS, CROTALUS HORRIDUS, BRYONIA, CALC. FLUOR., CARDUUS MAR., CHOLESTERINUM, CINCHONA, DIGITALIS, HAMAMELIS, HYDROFLUORICUM ACIDUM, LACHESIS, LYCOPODIUM, NAJA, PULSATILLA, VIPERA BERUS, ZINC. MET., AESCULUS HIPP., ECHINACEANewton Laboratories, Inc.91e8e37c-c654-6df9-e053-2995a90aafe12026-01-29WarningsExact identifier
ndc (product): 55714-2553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2553-15571425530130 mL in 1 BOTTLE, GLASS (55714-2553-1) 30 ml2019-08-300000-00-00NoNoCurrent