Allergiemittel

Product NDC
53499-3590
Requested package NDC
53499-3590-1
11-digit product format
534993590
Labeler code
53499
Product ID
53499-3590_e2937205-cb32-4342-bb47-77286a75fee5
Type
HUMAN OTC DRUG
Nonproprietary name
CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-28
Substance
CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT
Active strength
3; 3; 5 [hp_X]/1; [hp_X]/1; [hp_X]/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
Allergiemittel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARDIOSPERMUM HALICACABUM FLOWERING TOP3 [hp_X]/1
GALPHIMIA GLAUCA FLOWERING TOP3 [hp_X]/1
LUFFA OPERCULATA FRUIT5 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZP2508BRRInternal UNII lookup
93PH5Q8M7EInternal UNII lookup
C4MO6809HUInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8aa3cd06-5a3a-4a16-9784-fbac3fc9c97bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3590-1Allergiemittel4 in 1 CARTONTABLET47
53499-3590-1Allergiemittel10 in 1 BLISTER PACKTABLET107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3590ALLERGIEMITTEL (CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT ) TABLET [SCHWABE NORTH AMERICA, INC.]6Current NDC, Legacy NDC, 2 package rows20241022_8aa3cd06-5a3a-4a16-9784-fbac3fc9c97b.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
AllergiemittelCARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUITSchwabe North America, Inc.8aa3cd06-5a3a-4a16-9784-fbac3fc9c97b2025-11-25WarningsExact identifier
ndc (package): 53499-3590-1
ndc (product): 53499-3590
ndc11 (package): 53499359001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-3590-1534993590014 BLISTER PACK in 1 CARTON (53499-3590-1) / 10 TABLET in 1 BLISTER PACK4 blister pack2020-04-280000-00-00NoNoCurrent