FDA.reportPublic FDA data

Guaiacum

Manufacturer
Hahnemann Laboratories, INC.
Effective date
2022-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:06

Label at a glance#

ProductGuaiacum
Active ingredientGUAIACUM OFFICINALE RESIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaiacum 6C 5gGuaiacum 6C 5gGuaiacum 6C 30gGuaiacum 6C 30gGuaiacum 6C 100gGuaiacum 6C 100gGuaiacum 12C 5gGuaiacum 12C 5gGuaiacum 12C 30gGuaiacum 12C 30gGuaiacum 12C 100gGuaiacum 12C 100gGuaiacum 30C 1gGuaiacum 30C 1gGuaiacum 30C 5gGuaiacum 30C 5gGuaiacum 30C 30gGuaiacum 30C 30gGuaiacum 30C 100gGuaiacum 30C 100gGuaiacum 100C 1gGuaiacum 100C 1gGuaiacum 100C 5gGuaiacum 100C 5gGuaiacum 100C 30gGuaiacum 100C 30gGuaiacum 100C 100gGuaiacum 100C 100gGuaiacum 200C 1gGuaiacum 200C 1gGuaiacum 200C 5gGuaiacum 200C 5gGuaiacum 200C 30gGuaiacum 200C 30gGuaiacum 200C 100gGuaiacum 200C 100gGuaiacum 500C 1gGuaiacum 500C 1gGuaiacum 500C 5gGuaiacum 500C 5gGuaiacum 500C 30gGuaiacum 500C 30gGuaiacum 500C 100gGuaiacum 500C 100gGuaiacum 1M 1gGuaiacum 1M 1gGuaiacum 1M 5gGuaiacum 1M 5gGuaiacum 1M 30gGuaiacum 1M 30gGuaiacum 1M 100gGuaiacum 1M 100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37662-1482-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1482-2Guaiacum1200 in 1 BOTTLE, GLASSPELLET12001
37662-1482-3Guaiacum4000 in 1 BOTTLE, GLASSPELLET40001
37662-1483-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1483-2Guaiacum1200 in 1 BOTTLE, GLASSPELLET12001
37662-1483-3Guaiacum4000 in 1 BOTTLE, GLASSPELLET40001
37662-1484-1Guaiacum80 in 1 VIAL, GLASSPELLET801
37662-1484-2Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1484-3Guaiacum1200 in 1 BOTTLE, GLASSPELLET12001
37662-1484-4Guaiacum4000 in 1 BOTTLE, GLASSPELLET40001
37662-1485-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1485-2Guaiacum500 in 1 VIAL, GLASSPELLET5001
37662-1485-3Guaiacum3000 in 1 BOTTLE, GLASSPELLET30001
37662-1485-4Guaiacum10000 in 1 BOTTLE, GLASSPELLET100001
37662-1486-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1486-2Guaiacum500 in 1 VIAL, GLASSPELLET5001
37662-1486-3Guaiacum3000 in 1 BOTTLE, GLASSPELLET30001
37662-1486-4Guaiacum10000 in 1 BOTTLE, GLASSPELLET100001
37662-1487-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1487-2Guaiacum500 in 1 VIAL, GLASSPELLET5001
37662-1487-3Guaiacum3000 in 1 BOTTLE, GLASSPELLET30001
37662-1487-4Guaiacum10000 in 1 BOTTLE, GLASSPELLET100001
37662-1488-1Guaiacum200 in 1 VIAL, GLASSPELLET2001
37662-1488-2Guaiacum500 in 1 VIAL, GLASSPELLET5001
37662-1488-3Guaiacum3000 in 1 BOTTLE, GLASSPELLET30001
37662-1488-4Guaiacum10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-1482GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1483GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 3 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1484GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1485GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1486GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1487GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip
37662-1488GUAIACUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, Legacy NDC, 4 package rows20220910_e8207fc8-0aff-430b-e053-2995a90a9610.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37662-148237662-1482-1, 37662-1482-2, 37662-1482-3
37662-148337662-1483-1, 37662-1483-2, 37662-1483-3
37662-148437662-1484-1, 37662-1484-2, 37662-1484-3, 37662-1484-4
37662-148537662-1485-1, 37662-1485-2, 37662-1485-3, 37662-1485-4
37662-148637662-1486-1, 37662-1486-2, 37662-1486-3, 37662-1486-4
37662-148737662-1487-1, 37662-1487-2, 37662-1487-3, 37662-1487-4
37662-148837662-1488-1, 37662-1488-2, 37662-1488-3, 37662-1488-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB
SUCROSEC151H8M554IACT
GUAIACUM OFFICINALE RESINN0K2Z502R6ACTIB

Source Document#

Source XML

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
GuaiacumGUAIACUMHahnemann Laboratories, INC.e8207fc8-0aff-430b-e053-2995a90a96102022-09-07Exact identifier
ndc (package): 37662-1486-2
ndc (package): 37662-1487-1
ndc (package): 37662-1485-1
ndc (package): 37662-1486-3
ndc (package): 37662-1488-4
ndc (package): 37662-1484-2
ndc (package): 37662-1485-4
ndc (package): 37662-1487-4
ndc (package): 37662-1483-1
ndc (package): 37662-1486-1
ndc (package): 37662-1487-2
ndc (package): 37662-1482-3
ndc (package): 37662-1485-3
ndc (package): 37662-1482-1
ndc (package): 37662-1488-2
ndc (package): 37662-1483-2
ndc (package): 37662-1484-1
ndc (package): 37662-1484-4
ndc (package): 37662-1488-3
ndc (package): 37662-1484-3
ndc (package): 37662-1486-4
ndc (package): 37662-1488-1
ndc (package): 37662-1482-2
ndc (package): 37662-1485-2
ndc (package): 37662-1487-3
ndc (package): 37662-1483-3
ndc (product): 37662-1486
ndc (product): 37662-1488
ndc (product): 37662-1483
ndc (product): 37662-1484
ndc (product): 37662-1482
ndc (product): 37662-1487
ndc (product): 37662-1485
ndc11 (package): 37662148703
ndc11 (package): 37662148502
ndc11 (package): 37662148604
ndc11 (package): 37662148302
ndc11 (package): 37662148203
ndc11 (package): 37662148504
ndc11 (package): 37662148402
ndc11 (package): 37662148702
ndc11 (package): 37662148501
ndc11 (package): 37662148301
ndc11 (package): 37662148201
ndc11 (package): 37662148401
ndc11 (package): 37662148804
ndc11 (package): 37662148701
ndc11 (package): 37662148601
ndc11 (package): 37662148802
ndc11 (package): 37662148603
ndc11 (package): 37662148602
ndc11 (package): 37662148704
ndc11 (package): 37662148801
ndc11 (package): 37662148404
ndc11 (package): 37662148202
ndc11 (package): 37662148303
ndc11 (package): 37662148403
ndc11 (package): 37662148503
ndc11 (package): 37662148803
spl id: e8207fc8-0b00-430b-e053-2995a90a9610
spl set id: e8207fc8-0aff-430b-e053-2995a90a9610

Reported adverse events (FAERS/openFDA)#

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