FDA.reportPublic FDA data

Renatone

Product NDC
44911-0904
11-digit product format
449110904
Labeler code
44911
Product ID
44911-0904_42a3edb1-e870-417e-91e3-8db482f79e53
Type
HUMAN OTC DRUG
Nonproprietary name
Berberis Vulgaris, Solidago Virgaurea, Cantharis, Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Senecio Aureus, Staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-02-27
Substance
BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PACKERA AUREA WHOLE; STAPHISAGRIA MACROSPERMA SEED
Active strength
3; 3; 12; 12; 12; 12; 12; 12; 12 [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

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
Renatone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK3 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
LYTTA VESICATORIA12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
PROTORTONIA CACTI12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
PACKERA AUREA WHOLE12 [hp_X]/mL
STAPHISAGRIA MACROSPERMA SEED12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1TH8Q20J0UInternal UNII lookup
5405K23S50Internal UNII lookup
3Q034RO3BTInternal UNII lookup
S7V92P67HOInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
C88X29Y479Internal UNII lookup
27YLU75U4WInternal UNII lookup
5WS1632J8WInternal UNII lookup
00543AP1JVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2fbeb1b-a19f-4c09-947e-adbdabe256bfAvailable 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
44911-0904-1Renatone30 mL in 1 BOTTLE, DROPPERLIQUID301

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
RenatoneBERBERIS VULGARIS, SOLIDAGO VIRGAUREA, CANTHARIS, ARSENICUM ALBUM, COCCUS CACTI, LYCOPODIUM CLAVATUM, PHOSPHORUS, SENECIO AUREUS, STAPHYSAGRIAEnergique, Inc.c2fbeb1b-a19f-4c09-947e-adbdabe256bf2026-02-27WarningsExact identifier
ndc (product): 44911-0904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44911-0904-14491109040130 mL in 1 BOTTLE, DROPPER (44911-0904-1) 30 ml2026-02-27NoNoCurrent