Addex

Product NDC
83027-0044
11-digit product format
830270044
Labeler code
83027
Product ID
83027-0044_d983d2f4-ec2a-4c36-9a4e-abb3640a32fa
Type
HUMAN OTC DRUG
Nonproprietary name
Lappa Major, Plantago Major, Taraxacum Officinale, Glyphosate
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-02-24
Substance
ARCTIUM LAPPA ROOT; GLYPHOSATE; PLANTAGO MAJOR WHOLE; TARAXACUM OFFICINALE
Active strength
3; 12; 3; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Addex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARCTIUM LAPPA ROOT3 [hp_X]/mL
PLANTAGO MAJOR WHOLE12 [hp_C]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
GLYPHOSATE3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
597E9BI3Z3Internal UNII lookup
W2469WNO6UInternal UNII lookup
39981FM375Internal UNII lookup
4632WW1X5AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50318603-4f2e-461a-8efb-98f3873836b9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0044-1Addex60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0044ADDEX (LAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE, GLYPHOSATE) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230225_50318603-4f2e-461a-8efb-98f3873836b9.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
AddexLAPPA MAJOR, PLANTAGO MAJOR, TARAXACUM OFFICINALE, GLYPHOSATENutritional Specialties, Inc.50318603-4f2e-461a-8efb-98f3873836b92026-03-31WarningsExact identifier
ndc (product): 83027-0044

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0044-18302700440160 mL in 1 BOTTLE, SPRAY (83027-0044-1) 60 ml2023-02-24NoNoCurrent