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
GLYPHOSATE12 [hp_C]/mL
PLANTAGO MAJOR WHOLE3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii597E9BI3Z3, 4632WW1X5A, W2469WNO6U, 39981FM375

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

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