apo-TUSS

Product NDC
59469-104
11-digit product format
594690104
Labeler code
59469
Product ID
59469-104_d0974a83-5638-481c-8b47-77c313f15dd1
Type
HUMAN OTC DRUG
Nonproprietary name
Arum Maculatum Root, Bryonia Dioica Root, Protortonia Cacti, Cupric Acetate, Gelsemium sempervirens Root, Hedera helix Flowering Twig, Lactuca virosa, and Horseradish
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-12-11
Substance
ARUM MACULATUM ROOT; BRYONIA DIOICA ROOT; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; HEDERA HELIX FLOWERING TWIG; HORSERADISH; LACTUCA VIROSA WHOLE; PROTORTONIA CACTI
Active strength
4; 4; 4; 4; 6; 4; 4; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARUM MACULATUM ROOT4 [hp_X]/50mL
BRYONIA DIOICA ROOT4 [hp_X]/50mL
PROTORTONIA CACTI4 [hp_X]/50mL
CUPRIC ACETATE4 [hp_X]/50mL
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/50mL
HEDERA HELIX FLOWERING TWIG4 [hp_X]/50mL
LACTUCA VIROSA WHOLE4 [hp_X]/50mL
HORSERADISH2 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
646O39K8BJInternal UNII lookup
53UB5FH7CXInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
39M11XPH03Internal UNII lookup
639KR60Q1QInternal UNII lookup
3D10KUA6BMInternal UNII lookup
6D74QW4H67Internal UNII lookup
8DS6G120HJInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eebfdf25-1beb-4e31-b62d-967c8f1b9844Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-104-10apo-TUSS50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505
59469-104-10apo-TUSS1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-104APO-TUSS (ARUM MACULATUM ROOT, BRYONIA DIOICA ROOT, PROTORTONIA CACTI, CUPRIC ACETATE, GELSEMIUM SEMPERVIRENS ROOT, HEDERA HELIX FLOWERING TWIG, LACTUCA VIROSA, AND HORSERADISH) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221208_eebfdf25-1beb-4e31-b62d-967c8f1b9844.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
apo-TUSSARUM MACULATUM ROOT, BRYONIA DIOICA ROOT, PROTORTONIA CACTI, CUPRIC ACETATE, GELSEMIUM SEMPERVIRENS ROOT, HEDERA HELIX FLOWERING TWIG, LACTUCA VIROSA, AND HORSERADISHPEKANA Naturheilmittel GmbHeebfdf25-1beb-4e31-b62d-967c8f1b98442022-12-06WarningsExact identifier
ndc (product): 59469-104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-104-10594690104101 BOTTLE, GLASS in 1 BOX (59469-104-10) / 50 mL in 1 BOTTLE, GLASS2008-12-110000-00-00NoNoCurrent