FDA.reportPublic FDA data

Amebex

Product NDC
83027-0046
11-digit product format
830270046
Labeler code
83027
Product ID
83027-0046_3a1b9bf5-dda3-45d7-954f-02d9b9adb161
Type
HUMAN OTC DRUG
Nonproprietary name
Absinthium, Allium Sativum, Baptisia Tinctoria, Cinchona Officinalis, Ammonium Phosphoricum, Entamoeba Histolytica
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-04-24
Substance
WORMWOOD; GARLIC; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; AMMONIUM PHOSPHATE, DIBASIC; ENTAMOEBA HISTOLYTICA
Active strength
6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]
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
Amebex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WORMWOOD6 [hp_X]/mL
GARLIC6 [hp_X]/mL
BAPTISIA TINCTORIA ROOT6 [hp_X]/mL
CINCHONA OFFICINALIS BARK6 [hp_X]/mL
AMMONIUM PHOSPHATE, DIBASIC6 [hp_X]/mL
ENTAMOEBA HISTOLYTICA30 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F84709P2XVInternal UNII lookup
V1V998DC17Internal UNII lookup
5EF0HWI5WUInternal UNII lookup
S003A158SBInternal UNII lookup
10LGE70FSUInternal UNII lookup
2XC2HJ478WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e50da18e-7fc8-425d-8400-2f87c3b8015dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0046-1Amebex60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0046AMEBEX (ABSINTHIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CINCHONA OFFICINALIS, AMMONIUM PHOSPHORICUM, ENTAMOEBA HISTOLYTICA) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230425_e50da18e-7fc8-425d-8400-2f87c3b8015d.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
AmebexABSINTHIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CINCHONA OFFICINALIS, AMMONIUM PHOSPHORICUM, ENTAMOEBA HISTOLYTICANutritional Specialties, Inc.e50da18e-7fc8-425d-8400-2f87c3b8015d2023-04-24WarningsExact identifier
ndc (product): 83027-0046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0046-18302700460160 mL in 1 BOTTLE, SPRAY (83027-0046-1) 60 ml2023-04-24NoNoCurrent