Bladdertone

Product NDC
44911-0597
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]/mL
LYTTA VESICATORIA12 [hp_X]/mL
POPULUS TREMULOIDES WHOLE12 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SMILAX ORNATA ROOT3 [hp_X]/mL
TURPENTINE OIL12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M5V3D1X36, S7V92P67HO, 395A3P448Z, 3Q034RO3BT, MUN0TBE4PE, I76KB35JEV, QDL83WN8C2, 2H1576D5WG, C5H0QJ6V7F

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

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