Rosacea

Product NDC
55714-2510
11-digit product format
557142510
Labeler code
55714
Product ID
55714-2510_2dcfec93-7cea-5464-e063-6294a90a9b77
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea, Taraxacum officinale, Arsenicum album, Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle asiatica, Kali bromatum, Kali iodatum, Kreosotum, Lycopodium clavatum, Nux vomica, Petroleum, Rhus toxicodendron, Sepia, Sulphur
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ECHINACEA, UNSPECIFIED; ARSENIC TRIOXIDE; ARSENIC TRIBROMIDE; CARBO ANIMALIS; CAUSTICUM; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; TARAXACUM OFFICINALE
Active strength
6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2510-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2510-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2510-10efc9e666f02…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
Rosacea
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ARSENIC TRIBROMIDE15 [hp_X]/mL
CARBO ANIMALIS15 [hp_X]/mL
CAUSTICUM15 [hp_X]/mL
CENTELLA ASIATICA15 [hp_X]/mL
POTASSIUM BROMIDE15 [hp_X]/mL
POTASSIUM IODIDE15 [hp_X]/mL
WOOD CREOSOTE15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
KEROSENE15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL
SULFUR15 [hp_X]/mL
TARAXACUM OFFICINALE6 [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
S7V92P67HOInternal UNII lookup
41CN475O7FInternal UNII lookup
279O8I0433Internal UNII lookup
DD5FO1WKFUInternal UNII lookup
7M867G6T1UInternal UNII lookup
OSD78555ZMInternal UNII lookup
1C4QK22F9JInternal UNII lookup
3JYG22FD73Internal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
1C89KKC04EInternal UNII lookup
6IO182RP7AInternal UNII lookup
QDL83WN8C2Internal UNII lookup
70FD1KFU70Internal UNII lookup
39981FM375Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9caca164-0e81-7ed3-e053-2995a90a1244Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2510-1Rosacea30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2510ROSACEA (ECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHUR) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9caca164-0e81-7ed3-e053-2995a90a1244.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
RosaceaECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHURNewton Laboratories, Inc.9caca164-0e81-7ed3-e053-2995a90a12442025-02-10WarningsExact identifier
ndc (product): 55714-2510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2510-15571425100130 mL in 1 BOTTLE, GLASS (55714-2510-1) 30 ml2019-01-010000-00-00NoNoCurrent