FDA.reportPublic FDA data

Gallium Fluoratum

Product NDC
37662-2626
11-digit product format
376622626
Labeler code
37662
Product ID
37662-2626_f4133b5c-25ca-5a33-e053-2a95a90a8681
Type
HUMAN OTC DRUG
Nonproprietary name
Gallium Fluoratum
Dosage form
PELLET
Route
ORAL
Labeler
Hahnemann Laboratories, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-02-06
Substance
GALLIUM TRIFLUORIDE
Active strength
500 [hp_C]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALLIUM TRIFLUORIDE500 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3EG50JLZ49Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4133b5c-25c9-5a33-e053-2a95a90a8681Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37662-2626-1Gallium Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-2626-2Gallium Fluoratum500 in 1 VIAL, GLASSPELLET5001
37662-2626-3Gallium Fluoratum3000 in 1 BOTTLE, GLASSPELLET30001
37662-2626-4Gallium Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-2626GALLIUM FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230208_f4133b5c-25c9-5a33-e053-2a95a90a8681.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
Gallium FluoratumGALLIUM FLUORATUMHahnemann Laboratories, INC.f4133b5c-25c9-5a33-e053-2a95a90a86812023-02-06Exact identifier
ndc (product): 37662-2626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37662-2626-137662262601200 PELLET in 1 VIAL, GLASS (37662-2626-1) 200 pellet2023-02-06NoNoCurrent
37662-2626-237662262602500 PELLET in 1 VIAL, GLASS (37662-2626-2) 500 pellet2023-02-06NoNoCurrent
37662-2626-3376622626033000 PELLET in 1 BOTTLE, GLASS (37662-2626-3) 3000 pellet2023-02-06NoNoCurrent
37662-2626-43766226260410000 PELLET in 1 BOTTLE, GLASS (37662-2626-4) 10000 pellet2023-02-06NoNoCurrent