F03

Product NDC
63479-0603
11-digit product format
634790603
Labeler code
63479
Product ID
63479-0603_0e76e634-d944-70ac-e063-6294a90a6ad3
Type
HUMAN OTC DRUG
Nonproprietary name
ASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINE
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1996-03-12
Substance
AESCULUS CARNEA FLOWER; ALLIUM SATIVUM WHOLE; ARSENIC TRIOXIDE; DIPLACUS AURANTIACUS WHOLE; ERIOBOTRYA JAPONICA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHEMUM NUMMULARIUM FLOWER; LILIUM LANCIFOLIUM WHOLE FLOWERING; LUFFA OPERCULATA FRUIT; MIMULUS GUTTATUS FLOWERING TOP; PENSTEMON DAVIDSONII WHOLE; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; RUBUS URSINUS WHOLE; TOXICODENDRON DIVERSILOBUM WHOLE; VIOLA ODORATA FLOWER; WATERMELON
Active strength
12; 12; 20; 12; 12; 20; 12; 20; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
F03
Brand name suffix
FR-RLS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_C]/mL
VIOLA ODORATA FLOWER12 [hp_C]/mL
GELSEMIUM SEMPERVIRENS ROOT20 [hp_C]/mL
ERIOBOTRYA JAPONICA WHOLE12 [hp_C]/mL
LUFFA OPERCULATA FRUIT12 [hp_C]/mL
MIMULUS GUTTATUS FLOWERING TOP20 [hp_C]/mL
TOXICODENDRON DIVERSILOBUM WHOLE12 [hp_C]/mL
PENSTEMON DAVIDSONII WHOLE20 [hp_C]/mL
AESCULUS CARNEA FLOWER12 [hp_C]/mL
RUBUS URSINUS WHOLE12 [hp_C]/mL
PRUNUS CERASIFERA FLOWER12 [hp_C]/mL
ALLIUM SATIVUM WHOLE12 [hp_C]/mL
POPULUS TREMULA FLOWERING TOP12 [hp_C]/mL
DIPLACUS AURANTIACUS WHOLE12 [hp_C]/mL
HELIANTHEMUM NUMMULARIUM FLOWER12 [hp_C]/mL
WATERMELON12 [hp_C]/mL
LILIUM LANCIFOLIUM WHOLE FLOWERING12 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 17 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
438W01FC7AInternal UNII lookup
639KR60Q1QInternal UNII lookup
2FCJ9QNJ7OInternal UNII lookup
C4MO6809HUInternal UNII lookup
192426I5JUInternal UNII lookup
9211E5735BInternal UNII lookup
8K9DCX606ZInternal UNII lookup
717DPT98VMInternal UNII lookup
EB3AN7DKSLInternal UNII lookup
0KD7R09EASInternal UNII lookup
IIF21WT8O3Internal UNII lookup
5Q01F7TPJJInternal UNII lookup
TO6G4140YAInternal UNII lookup
51BRR32WPPInternal UNII lookup
231473QB6RInternal UNII lookup
X67Z2963PIInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bccede22-e48f-52bc-e053-2995a90a6d0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0603-1F03FR-RLS30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0603F03 FR-RLS (ASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINE) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bccede22-e48f-52bc-e053-2995a90a6d0f.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
F03 FR-RLSASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINEApex Energetics Inc.bccede22-e48f-52bc-e053-2995a90a6d0f2024-01-08WarningsExact identifier
ndc (product): 63479-0603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0603-16347906030130 mL in 1 BOTTLE, GLASS (63479-0603-1) 30 ml1996-03-120000-00-00NoNoCurrent