FDA.reportPublic FDA data

AZZURX

Product NDC
83243-001
11-digit product format
832430001
Labeler code
83243
Product ID
83243-001_29f05aaf-89b2-e293-e063-6394a90ad0e5
Type
HUMAN OTC DRUG
Nonproprietary name
MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALlS
Dosage form
LIQUID
Route
TOPICAL
Labeler
Outbreaks, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-02-13
Substance
CALENDULA OFFICINALIS FLOWER; GERANIUM MACULATUM ROOT; MELISSA OFFICINALIS LEAF; THUJA OCCIDENTALIS LEAF
Active strength
3; 3; 3; 3 [hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL; [hp_X]/.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWER3 [hp_X]/.5mL
GERANIUM MACULATUM ROOT3 [hp_X]/.5mL
MELISSA OFFICINALIS LEAF3 [hp_X]/.5mL
THUJA OCCIDENTALIS LEAF3 [hp_X]/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP0M7O4Y7YD, 93IXI5B6OJ, 50D2ZE9219, 0T0DQN8786

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83243-001-01AZZURX3 in 1 PACKAGELIQUID33
83243-001-01AZZURX0.5 mL in 1 APPLICATORLIQUID0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83243-001AZZURX (MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALLS) LIQUID [OUTBREAKS, INC.]3Current NDC, 2 package rows20250116_9e48aaac-48c2-451d-9f6f-369e65c1c52b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83243-001-01832430001013 APPLICATOR in 1 PACKAGE (83243-001-01) / .5 mL in 1 APPLICATOR3 applicator2023-02-13NoNoCurrent