Vitiligo

Product NDC
55714-2592
11-digit product format
557142592
Labeler code
55714
Product ID
55714-2592_136939aa-bd34-38a6-e063-6394a90abad0
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Iris versicolor, Rumex crispus, Berberis vulgaris, Bovista, Dolichos pruriens, Hura brasiliensis, Hydrocotyle asiatica, Lycopodium clavatum, Mezereum, Rhus toxicodendron, Sepia, Taraxacum officinale, Thuja occidentalis, Urtica urens, Arsenicum album
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-11
Substance
ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; IRIS VERSICOLOR ROOT; LYCOPERDON UTRIFORME FRUITING BODY; LYCOPODIUM CLAVATUM SPORE; MUCUNA PRURIENS FRUIT TRICHOME; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA URENS
Active strength
15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
HURA CREPITANS SAP15 [hp_X]/mL
CENTELLA ASIATICA15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
RUMEX CRISPUS ROOT6 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL
TARAXACUM OFFICINALE15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
URTICA URENS15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK15 [hp_X]/mL
IRIS VERSICOLOR ROOT15 [hp_X]/mL
LYCOPERDON UTRIFORME FRUITING BODY15 [hp_X]/mL
MUCUNA PRURIENS FRUIT TRICHOME15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4N9P6CC1DXInternal UNII lookup
8UHN1I06UPInternal UNII lookup
7M867G6T1UInternal UNII lookup
C88X29Y479Internal UNII lookup
X2N6E405GVInternal UNII lookup
6IO182RP7AInternal UNII lookup
9N1RM2S62CInternal UNII lookup
QDL83WN8C2Internal UNII lookup
39981FM375Internal UNII lookup
1NT28V9397Internal UNII lookup
IHN2NQ5OF9Internal UNII lookup
S7V92P67HOInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
X43D4L3DQCInternal UNII lookup
K2A74U428FInternal UNII lookup
3E271BSI0CInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
136945e2-6f2a-a0df-e063-6294a90a994bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2592-1Vitiligo30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2592VITILIGO (ECHINACEA, IRIS VERSICOLOR, RUMEX CRISPUS, BERBERIS VULGARIS, BOVISTA, DOLICHOS PRURIENS, HURA BRASILIENSIS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MEZEREUM, RHUS TOXICODENDRON, SEPIA, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, URTICA URENS, ARSENICUM ALBUM) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240313_136945e2-6f2a-a0df-e063-6294a90a994b.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
VitiligoECHINACEA, IRIS VERSICOLOR, RUMEX CRISPUS, BERBERIS VULGARIS, BOVISTA, DOLICHOS PRURIENS, HURA BRASILIENSIS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MEZEREUM, RHUS TOXICODENDRON, SEPIA, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, URTICA URENS, ARSENICUM ALBUMNewton Laboratories, Inc.136945e2-6f2a-a0df-e063-6294a90a994b2024-03-11WarningsExact identifier
ndc (product): 55714-2592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2592-15571425920130 mL in 1 BOTTLE, GLASS (55714-2592-1) 30 ml2024-03-11NoNoCurrent