RENELIX

Product NDC
59469-315
11-digit product format
594690315
Labeler code
59469
Product ID
59469-315_8ddbd870-0a08-4be8-8d59-b56c164cd02f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoic Acid, Nitric Acid, Apis mellifera, Berberis Vulgaris Root Bark, Colchicum autumnale Bulb, Protortonia Cacti, Solidago virgaurea Flowering Top, and Capsella bursa-pastoris Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
APIS MELLIFERA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CAPSELLA BURSA-PASTORIS TOP; COLCHICUM AUTUMNALE BULB; NITRIC ACID; PROTORTONIA CACTI; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
4; 4; 3; 510; 12; 6; 631; 2913 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL
Pharmacologic classes
Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOIC ACID4 [hp_X]/50mL
NITRIC ACID6 [hp_X]/50mL
APIS MELLIFERA4 [hp_X]/50mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/50mL
COLCHICUM AUTUMNALE BULB12 [hp_X]/50mL
PROTORTONIA CACTI631 mg/50mL
SOLIDAGO VIRGAUREA FLOWERING TOP2913 mg/50mL
CAPSELLA BURSA-PASTORIS TOP510 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8SKN0B0MIMInternal UNII lookup
411VRN1TV4Internal UNII lookup
7S82P3R43ZInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
993QHL78E6Internal UNII lookup
LZB7TFX1LTInternal UNII lookup
5405K23S50Internal UNII lookup
7D8DU3293GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11a057e9-4b2a-4de0-a7e9-fbd4029bb7a8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-315-10RENELIX1 in 1 BOXSOLUTION/ DROPS12
59469-315-10RENELIX50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-315-40RENELIX1 in 1 BOXSOLUTION/ DROPS12
59469-315-40RENELIX100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-315RENELIX (BENZOIC ACID, NITRIC ACID, APIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, COLCHICUM AUTUMNALE BULB, PROTORTONIA CACTI, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CAPSELLA BURSA-PASTORIS TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 4 package rows20230113_11a057e9-4b2a-4de0-a7e9-fbd4029bb7a8.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
RENELIXBENZOIC ACID, NITRIC ACID, APIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, COLCHICUM AUTUMNALE BULB, PROTORTONIA CACTI, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CAPSELLA BURSA-PASTORIS TOPPEKANA Naturheilmittel GmbH11a057e9-4b2a-4de0-a7e9-fbd4029bb7a82023-01-11WarningsExact identifier
ndc (product): 59469-315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-315-10594690315101 BOTTLE, GLASS in 1 BOX (59469-315-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent
59469-315-40594690315401 BOTTLE, GLASS in 1 BOX (59469-315-40) / 100 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent