FDA.reportPublic FDA data

Umcka FastActives Berry

Product NDC
53499-9349
11-digit product format
534999349
Labeler code
53499
Product ID
53499-9349_ce73b91f-d303-4b7a-98eb-31ca9bca585d
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus
Dosage form
POWDER
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-04-14
Marketing end
2026-12-31
Substance
ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS
Active strength
4; 4; 2; 6; 4; 3; 1; 6 [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka FastActives Berry

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT4 [hp_X]/912mg
ACONITUM NAPELLUS4 [hp_X]/912mg
EUCALYPTUS GLOBULUS LEAF2 [hp_X]/912mg
BRYONIA ALBA ROOT6 [hp_X]/912mg
EUPATORIUM PERFOLIATUM FLOWERING TOP4 [hp_X]/912mg
GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]/912mg
PHOSPHORUS1 [hp_X]/912mg
IPECAC6 [hp_X]/912mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup
U0NQ8555JDInternal UNII lookup
S546YLW6E6Internal UNII lookup
T7J046YI2BInternal UNII lookup
1W0775VX6EInternal UNII lookup
639KR60Q1QInternal UNII lookup
27YLU75U4WInternal UNII lookup
62I3C8233LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
149941fb-9b5f-42f2-bf0c-e5980f7daad6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-9349-0Umcka FastActives Berry10 in 1 CARTONPOWDER109
53499-9349-0Umcka FastActives Berry912 mg in 1 PACKETPOWDER9129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-9349-0EA - Each53499-9349a801c212-4643-4a61-8f61-f5a2f4ab34ed12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-9349UMCKA FASTACTIVES BERRY (PELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUS) POWDER [SCHWABE NORTH AMERICA, INC]9Current NDC, Legacy NDC, 2 package rows20241025_149941fb-9b5f-42f2-bf0c-e5980f7daad6.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
Umcka FastActives BerryPELARGONIUM SIDOIDES, ACONITUM NAPELLUS, BRYONIA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PHOSPHORUSSchwabe North America, Inc149941fb-9b5f-42f2-bf0c-e5980f7daad62024-10-23WarningsExact identifier
ndc (product): 53499-9349

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-9349-05349993490010 PACKET in 1 CARTON (53499-9349-0) / 912 mg in 1 PACKET10 packet2017-04-142026-12-31NoNoCurrent