FDA.reportPublic FDA data

OSS-regen

Product NDC
59469-153
11-digit product format
594690153
Labeler code
59469
Product ID
59469-153_737b125d-ff36-44d8-8530-0df981265402
Type
HUMAN OTC DRUG
Nonproprietary name
Phosphoric Acid, Angostura Bark, Ferula Assa-Foetida Resin, Bellis Perennis, Bryonia Dioica Root, Guaiacum officinale Resin, Ruta graveolens Flowering Top, and Equisetum arvense Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
PHOSPHORIC ACID; ANGOSTURA BARK; FERULA ASSA-FOETIDA RESIN; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RUTA GRAVEOLENS FLOWERING TOP; EQUISETUM ARVENSE TOP
Active strength
3; 4; 3; 3; 4; 3; 3; 2481 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
OSS-regen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHOSPHORIC ACID3 [hp_X]/100mL
ANGOSTURA BARK4 [hp_X]/100mL
FERULA ASSA-FOETIDA RESIN3 [hp_X]/100mL
BELLIS PERENNIS WHOLE3 [hp_X]/100mL
BRYONIA DIOICA ROOT4 [hp_X]/100mL
GUAIACUM OFFICINALE RESIN3 [hp_X]/100mL
RUTA GRAVEOLENS FLOWERING TOP3 [hp_X]/100mL
EQUISETUM ARVENSE TOP2481 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E4GA8884NNInternal UNII lookup
104010O5VUInternal UNII lookup
W9FZA51AS1Internal UNII lookup
2HU33I03UYInternal UNII lookup
53UB5FH7CXInternal UNII lookup
N0K2Z502R6Internal UNII lookup
N94C2U587SInternal UNII lookup
1DP6Y6B65ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83fcf98d-4d5a-49f4-9ea1-816515a64f77Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-153-30OSS-regen1 in 1 BOXSOLUTION/ DROPS15
59469-153-30OSS-regen100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-153OSS-REGEN (PHOSPHORIC ACID, ANGOSTURA BARK, FERULA ASSA-FOETIDA RESIN, BELLIS PERENNIS, BRYONIA DIOICA ROOT, GUAIACUM OFFICINALE RESIN, RUTA GRAVEOLENS FLOWERING TOP, AND EQUISETUM ARVENSE TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221221_83fcf98d-4d5a-49f4-9ea1-816515a64f77.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
OSS-regenPHOSPHORIC ACID, ANGOSTURA BARK, FERULA ASSA-FOETIDA RESIN, BELLIS PERENNIS, BRYONIA DIOICA ROOT, GUAIACUM OFFICINALE RESIN, RUTA GRAVEOLENS FLOWERING TOP, AND EQUISETUM ARVENSE TOPPEKANA Naturheilmittel GmbH83fcf98d-4d5a-49f4-9ea1-816515a64f772022-12-16WarningsExact identifier
ndc (product): 59469-153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-153-30594690153301 BOTTLE, GLASS in 1 BOX (59469-153-30) / 100 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent