FDA.reportPublic FDA data

S01

Product NDC
63479-1901
11-digit product format
634791901
Labeler code
63479
Product ID
63479-1901_0e775a95-3ba3-f934-e063-6394a90a314f
Type
HUMAN OTC DRUG
Nonproprietary name
aloe socotrina, berberis vulgaris, betula verrucosa, bryonia, carduus marianus, echinacea angustifolia, ginkgo biloba, histaminum hydrochloricum, juniperus communis, lycopodium clavatum, melaleuca alternifolia oil, quercus robur, rhamnus purshiana, ribes nigrum, rosa canina, rosmarinus officinalis, scrophularia nodosa, senna, solidago virgaurea, taraxacum officinale, vaccinium vitus idaea
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1993-03-15
Substance
LYCOPODIUM CLAVATUM SPORE; FRANGULA PURSHIANA BARK; QUERCUS ROBUR FLOWER BUD; RIBES NIGRUM FLOWER BUD; ROSA CANINA LEAF; SCROPHULARIA NODOSA; MILK THISTLE; GINKGO; HISTAMINE DIHYDROCHLORIDE; TEA TREE OIL; ROSMARINUS OFFICINALIS FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BETULA PENDULA LEAF; BRYONIA ALBA ROOT; ALOE; JUNIPERUS COMMUNIS STEM; VACCINIUM VITIS-IDAEA LEAF; ECHINACEA ANGUSTIFOLIA; TARAXACUM OFFICINALE; SENNA LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
4; 1; 2; 2; 2; 2; 2; 2; 200; 12; 2; 1; 2; 1; 3; 2; 2; 2; 2; 2; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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
S01
Brand name suffix
ALLERDRAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LYCOPODIUM CLAVATUM SPORE4 [hp_X]/mL
FRANGULA PURSHIANA BARK1 [hp_X]/mL
QUERCUS ROBUR FLOWER BUD2 [hp_X]/mL
RIBES NIGRUM FLOWER BUD2 [hp_X]/mL
ROSA CANINA LEAF2 [hp_X]/mL
SCROPHULARIA NODOSA2 [hp_X]/mL
MILK THISTLE2 [hp_X]/mL
GINKGO2 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE200 [hp_X]/mL
TEA TREE OIL12 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP2 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK1 [hp_X]/mL
BETULA PENDULA LEAF2 [hp_X]/mL
BRYONIA ALBA ROOT1 [hp_X]/mL
ALOE3 [hp_X]/mL
JUNIPERUS COMMUNIS STEM2 [hp_X]/mL
VACCINIUM VITIS-IDAEA LEAF2 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA2 [hp_X]/mL
TARAXACUM OFFICINALE2 [hp_X]/mL
SENNA LEAF2 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C88X29Y479Internal UNII lookup
4VBP01X99FInternal UNII lookup
VC5I578BE3Internal UNII lookup
VYH9Y9BCCPInternal UNII lookup
J3N2Z889QPInternal UNII lookup
7H443NUB2TInternal UNII lookup
U946SH95EEInternal UNII lookup
19FUJ2C58TInternal UNII lookup
3POA0Q644UInternal UNII lookup
VIF565UC2GInternal UNII lookup
8JM482TI79Internal UNII lookup
1TH8Q20J0UInternal UNII lookup
5HW39H9KDHInternal UNII lookup
T7J046YI2BInternal UNII lookup
V5VD430YW9Internal UNII lookup
HBU87MH6OYInternal UNII lookup
FO2ACM0RMQInternal UNII lookup
VB06AV5US8Internal UNII lookup
39981FM375Internal UNII lookup
AK7JF626KXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9d2a7ef-28bd-4882-e053-2a95a90a0fddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1901-1S01ALLERDRAIN30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1901S01 ALLERDRAIN (ALOE SOCOTRINA, BERBERIS VULGARIS, BETULA VERRUCOSA, BRYONIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GINKGO BILOBA, HISTAMINUM HYDROCHLORICUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MELALEUCA ALTERNIFOLIA OIL, QUERCUS ROBUR, RHAMNUS PURSHIANA, RIBES NIGRUM, ROSA CANINA, ROSMARINUS OFFICINALIS, SCROPHULARIA NODOSA, SENNA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, VACCINIUM VITUS IDAEA) SOLUTION/ DROPS [APEX ENERGETICS INC.]3Current NDC, Legacy NDC, 1 package rows20240110_b9d2a7ef-28bd-4882-e053-2a95a90a0fdd.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
S01 ALLERDRAINALOE SOCOTRINA, BERBERIS VULGARIS, BETULA VERRUCOSA, BRYONIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GINKGO BILOBA, HISTAMINUM HYDROCHLORICUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MELALEUCA ALTERNIFOLIA OIL, QUERCUS ROBUR, RHAMNUS PURSHIANA, RIBES NIGRUM, ROSA CANINA, ROSMARINUS OFFICINALIS, SCROPHULARIA NODOSA, SENNA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, VACCINIUM VITUS IDAEAApex Energetics Inc.b9d2a7ef-28bd-4882-e053-2a95a90a0fdd2024-01-08WarningsExact identifier
ndc (product): 63479-1901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-1901-16347919010130 mL in 1 BOTTLE, GLASS (63479-1901-1) 30 ml1993-03-150000-00-00NoNoCurrent