FDA.reportPublic FDA data

SEPTONSIL

Product NDC
59469-316
11-digit product format
594690316
Labeler code
59469
Product ID
59469-316_132810e3-4dff-4f49-9578-1318b30aefee
Type
HUMAN OTC DRUG
Nonproprietary name
Ailanthus altissima Whole, Atropa bella-donna Flowering Top, Barium Carbonate, Lachesis Muta Venom, Phytolacca americana Root, Clematis recta Flowering Top, Echinacea, unspecified, and Teucrium scorodonia Flowering Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
AILANTHUS ALTISSIMA WHOLE; ATROPA BELLA-DONNA FLOWERING TOP; BARIUM CARBONATE; CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TEUCRIUM SCORODONIA FLOWERING TOP
Active strength
3; 4; 8; 4; 6; 8; 4; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AILANTHUS ALTISSIMA WHOLE3 [hp_X]/50mL
ATROPA BELLA-DONNA FLOWERING TOP4 [hp_X]/50mL
BARIUM CARBONATE8 [hp_X]/50mL
LACHESIS MUTA VENOM4 [hp_X]/50mL
PHYTOLACCA AMERICANA ROOT6 [hp_X]/50mL
CLEMATIS RECTA FLOWERING TOP8 [hp_X]/50mL
ECHINACEA, UNSPECIFIED4 [hp_X]/50mL
TEUCRIUM SCORODONIA FLOWERING TOP12 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5G78C6GB5EInternal UNII lookup
B26WXN5GZJInternal UNII lookup
6P669D8HQ8Internal UNII lookup
VSW71SS07IInternal UNII lookup
11E6VI8VEGInternal UNII lookup
396421SP9FInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
LOK3I16O7GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42c00bac-6623-43b8-a871-895f13205f79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-316-10SEPTONSIL1 in 1 BOXSOLUTION/ DROPS12
59469-316-10SEPTONSIL50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-316SEPTONSIL (AILANTHUS ALTISSIMA WHOLE, ATROPA BELLA-DONNA FLOWERING TOP, BARIUM CARBONATE, LACHESIS MUTA VENOM, PHYTOLACCA AMERICANA ROOT, CLEMATIS RECTA FLOWERING TOP, ECHINACEA, UNSPECIFIED, AND TEUCRIUM SCORODONIA FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_42c00bac-6623-43b8-a871-895f13205f79.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
SEPTONSILAILANTHUS ALTISSIMA WHOLE, ATROPA BELLA-DONNA FLOWERING TOP, BARIUM CARBONATE, LACHESIS MUTA VENOM, PHYTOLACCA AMERICANA ROOT, CLEMATIS RECTA FLOWERING TOP, ECHINACEA, UNSPECIFIED, AND TEUCRIUM SCORODONIA FLOWERING TOPPEKANA Naturheilmittel GmbH42c00bac-6623-43b8-a871-895f13205f792023-01-11WarningsExact identifier
ndc (product): 59469-316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-316-10594690316101 BOTTLE, GLASS in 1 BOX (59469-316-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent