Helico 12X

Product NDC
44911-0599
11-digit product format
449110599
Labeler code
44911
Product ID
44911-0599_576fa33c-ce07-4feb-881b-0e1400e444ff
Type
HUMAN OTC DRUG
Nonproprietary name
Helicobacter Pylori
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-04-22
Substance
HELICOBACTER PYLORI
Active strength
12 [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
Helico 12X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELICOBACTER PYLORI12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U09W5JOL3ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8f938ce-8751-4db1-8d3c-3b662f55980cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0599-12024-01-23C16284748780-1f386c64a-2461-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0599-12023-01-30C16284748780-1f386c64a-2461-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0599-1Helico 12X30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0599HELICO 12X (HELICOBACTER PYLORI) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240124_f8f938ce-8751-4db1-8d3c-3b662f55980c.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
Helico 12XHELICOBACTER PYLORIEnergique, Inc.f8f938ce-8751-4db1-8d3c-3b662f55980c2024-01-23WarningsExact identifier
ndc (product): 44911-0599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0599-14491105990130 mL in 1 BOTTLE, DROPPER (44911-0599-1) 30 ml2021-04-220000-00-00NoNoCurrent