FDA.reportPublic FDA data

AZZURX

Product NDC
83243-001
Requested package NDC
83243-001-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83243-00183243-001-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50D2ZE9219Internal UNII lookup
0T0DQN8786Internal UNII lookup
93IXI5B6OJInternal UNII lookup
P0M7O4Y7YDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e48aaac-48c2-451d-9f6f-369e65c1c52bAvailable on FDA.report

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

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
AZZURXMELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALLSOutbreaks, Inc.9e48aaac-48c2-451d-9f6f-369e65c1c52b2025-01-14WarningsExact identifier
ndc (package): 83243-001-01
ndc (product): 83243-001
ndc11 (package): 83243000101

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