Bladdertone

Product NDC
44911-0597
Requested package NDC
44911-0597-1
11-digit product format
449110597
Labeler code
44911
Product ID
44911-0597_e83af16c-70bb-463e-a238-e1d1b314c4ff
Type
HUMAN OTC DRUG
Nonproprietary name
Sarsaparilla, Uva-Ursi, Arsenicum Album, Cantharis, Pareira Brava, Pulsatilla, Sepia, Terebinthina, Populus Tremuloides
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-21
Substance
ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; CHONDRODENDRON TOMENTOSUM ROOT; LYTTA VESICATORIA; POPULUS TREMULOIDES WHOLE; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SMILAX ORNATA ROOT; TURPENTINE OIL
Active strength
3; 12; 12; 12; 12; 12; 12; 3; 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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SMILAX ORNATA ROOT3 [hp_X]/mL
ARCTOSTAPHYLOS UVA-URSI LEAF12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
LYTTA VESICATORIA12 [hp_X]/mL
CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
TURPENTINE OIL3 [hp_X]/mL
POPULUS TREMULOIDES WHOLE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2H1576D5WGInternal UNII lookup
3M5V3D1X36Internal UNII lookup
S7V92P67HOInternal UNII lookup
3Q034RO3BTInternal UNII lookup
395A3P448ZInternal UNII lookup
I76KB35JEVInternal UNII lookup
QDL83WN8C2Internal UNII lookup
C5H0QJ6V7FInternal UNII lookup
MUN0TBE4PEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
125d7369-f384-4bc1-a1a3-40e8d6a9ea8cAvailable 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0597-12024-07-23C16284748780-1f386c64a-1f11-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0597-12023-01-30C16284748780-1f386c64a-1f11-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0597-1Bladdertone30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0597BLADDERTONE (SARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDES) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240724_125d7369-f384-4bc1-a1a3-40e8d6a9ea8c.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
BladdertoneSARSAPARILLA, UVA-URSI, ARSENICUM ALBUM, CANTHARIS, PAREIRA BRAVA, PULSATILLA, SEPIA, TEREBINTHINA, POPULUS TREMULOIDESEnergique, Inc.125d7369-f384-4bc1-a1a3-40e8d6a9ea8c2024-07-22WarningsExact identifier
ndc (package): 44911-0597-1
ndc (product): 44911-0597
ndc11 (package): 44911059701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0597-14491105970130 mL in 1 BOTTLE, DROPPER (44911-0597-1) 30 ml2020-12-210000-00-00NoNoCurrent