FDA.reportPublic FDA data

F14

Product NDC
63479-0614
11-digit product format
634790614
Labeler code
63479
Product ID
63479-0614_0e76cbc6-8d03-7dc8-e063-6294a90a815a
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA, ARNICA MONTANA, CALOCHORTUS GUNNISONII, CHERRY PLUM, CLEMATIS VITALBA, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, ENGLISH HAWTHRON, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, ORNITHOGALUM UMBELLATUM, PRUNELLA VULGARIS, ROCKROSE, RUTA GRAVEOLENS, STAPHYSAGRIA
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1996-03-12
Substance
ARNICA MONTANA; ARNICA MONTANA FLOWER; CALOCHORTUS GUNNISONII WHOLE; CLEMATIS VITALBA FLOWER; CRATAEGUS MONOGYNA FLOWER; DELPHINIUM STAPHISAGRIA SEED; DICENTRA FORMOSA WHOLE; EHRENDORFERIA CHRYSANTHA WHOLE; HELIANTHEMUM NUMMULARIUM FLOWER; HYPERICUM PERFORATUM; HYPERICUM PERFORATUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNELLA VULGARIS FLOWER; PRUNUS CERASIFERA FLOWER; RUTA GRAVEOLENS FLOWERING TOP; STRYCHNOS IGNATII SEED
Active strength
30; 12; 12; 12; 12; 12; 12; 12; 12; 20; 12; 12; 12; 12; 12; 15; 15 [hp_X]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
F14
Brand name suffix
INCDNT-RLS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS VITALBA FLOWER30 [hp_X]/mL
DICENTRA FORMOSA WHOLE12 [hp_C]/mL
CRATAEGUS MONOGYNA FLOWER12 [hp_C]/mL
EHRENDORFERIA CHRYSANTHA WHOLE12 [hp_C]/mL
HELIANTHEMUM NUMMULARIUM FLOWER12 [hp_C]/mL
RUTA GRAVEOLENS FLOWERING TOP12 [hp_C]/mL
ARNICA MONTANA12 [hp_C]/mL
ARNICA MONTANA FLOWER12 [hp_C]/mL
PRUNUS CERASIFERA FLOWER12 [hp_C]/mL
HYPERICUM PERFORATUM FLOWER20 [hp_X]/mL
HYPERICUM PERFORATUM12 [hp_C]/mL
PRUNELLA VULGARIS FLOWER12 [hp_C]/mL
CALOCHORTUS GUNNISONII WHOLE12 [hp_C]/mL
STRYCHNOS IGNATII SEED12 [hp_C]/mL
IMPATIENS GLANDULIFERA FLOWER12 [hp_C]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP15 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED15 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 17 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7SCP4N87CIInternal UNII lookup
6OFG7K362RInternal UNII lookup
NT52AMP29JInternal UNII lookup
68HKD4QMJRInternal UNII lookup
51BRR32WPPInternal UNII lookup
N94C2U587SInternal UNII lookup
O80TY208ZWInternal UNII lookup
OZ0E5Y15PZInternal UNII lookup
0KD7R09EASInternal UNII lookup
A6V4CUE7PVInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
AT1FD041EFInternal UNII lookup
H4ORZ75P00Internal UNII lookup
1NM3M2487KInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
CZD6M4PY4BInternal UNII lookup
00543AP1JVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf517ae5-84e8-5e7e-e053-2a95a90af220Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0614-1F14INCDNT-RLS30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0614F14 INCDNT-RLS (ARNICA MONTANA, ARNICA MONTANA, CALOCHORTUS GUNNISONII, CHERRY PLUM, CLEMATIS VITALBA, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, ENGLISH HAWTHRON, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, ORNITHOGALUM UMBELLATUM, PRUNELLA VULGARIS, ROCKROSE, RUTA GRAVEOLENS, STAPHYSAGRIA) SOLUTION/ DROPS [APEX ENERGETICS INC.]3Current NDC, Legacy NDC, 1 package rows20240110_bf517ae5-84e8-5e7e-e053-2a95a90af220.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
F14 INCDNT-RLSARNICA MONTANA, ARNICA MONTANA, CALOCHORTUS GUNNISONII, CHERRY PLUM, CLEMATIS VITALBA, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, ENGLISH HAWTHRON, HYPERICUM PERFORATUM, IGNATIA AMARA, IMPATIENS GLANDULIFERA, ORNITHOGALUM UMBELLATUM, PRUNELLA VULGARIS, ROCKROSE, RUTA GRAVEOLENS, STAPHYSAGRIAApex Energetics Inc.bf517ae5-84e8-5e7e-e053-2a95a90af2202024-01-08WarningsExact identifier
ndc (product): 63479-0614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0614-16347906140130 mL in 1 BOTTLE, GLASS (63479-0614-1) 30 ml1996-03-120000-00-00NoNoCurrent