FDA.reportPublic FDA data

LUMOe SKIN2 Skin Sensitivity

Product NDC
81425-008
11-digit product format
814250008
Labeler code
81425
Product ID
81425-008_63990c61-76eb-4696-9b52-e619db6c1c86
Type
HUMAN OTC DRUG
Nonproprietary name
Spigelia anthelmia, Phytolacca decandra, Oleander, Clematis erecta
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Applied Bioenergetics, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-09-27
Substance
CLEMATIS RECTA FLOWERING TOP; NERIUM OLEANDER LEAF; PHYTOLACCA AMERICANA ROOT; SPIGELIA ANTHELMIA
Active strength
12; 12; 12; 12 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LUMOe SKIN2 Skin Sensitivity
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIGELIA ANTHELMIA12 [hp_C]/1
PHYTOLACCA AMERICANA ROOT12 [hp_C]/1
NERIUM OLEANDER LEAF12 [hp_C]/1
CLEMATIS RECTA FLOWERING TOP12 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WYT05213GEInternal UNII lookup
11E6VI8VEGInternal UNII lookup
7KV510R6H6Internal UNII lookup
396421SP9FInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13a662fb-53b6-4449-99b7-2e50fef7a6a6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81425-008-10LUMOe SKIN2 Skin Sensitivity180 in 1 BOTTLETABLET, CHEWABLE1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81425-008LUMOE SKIN2 SKIN SENSITIVITY (SPIGELIA ANTHELMIA, PHYTOLACCA DECANDRA, OLEANDER, CLEMATIS ERECTA) TABLET, CHEWABLE [APPLIED BIOENERGETICS, LLC]1Current NDC, 1 package rows20241003_13a662fb-53b6-4449-99b7-2e50fef7a6a6.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
LUMOe SKIN2 Skin SensitivitySPIGELIA ANTHELMIA, PHYTOLACCA DECANDRA, OLEANDER, CLEMATIS ERECTAApplied Bioenergetics, LLC13a662fb-53b6-4449-99b7-2e50fef7a6a62025-11-10WarningsExact identifier
ndc (product): 81425-008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81425-008-1081425000810180 TABLET, CHEWABLE in 1 BOTTLE (81425-008-10) 2024-09-27NoNoCurrent