F08

Product NDC
63479-0608
11-digit product format
634790608
Labeler code
63479
Product ID
63479-0608_0e76f50e-2564-d499-e063-6394a90aa92e
Type
HUMAN OTC DRUG
Nonproprietary name
ALLEGHENY MONKEYFLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS, EHRENDORFERIA CHRYSANTHA, FAGUS SYLVATICA FLOWER, IGNATIA AMARA, ILEX AQUIFOLIUM FLOWER, MALUS SYLVESTRIS FLOWER, MULLEIN FLOWER, NETTLELEAF GIANT HYSSOP, PINUS SYLVESTRIS FLOWER, SALIX ALBA FLOWER
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1996-03-12
Substance
AGASTACHE URTICIFOLIA WHOLE; ARNICA MONTANA; ARNICA MONTANA FLOWER; CEANOTHUS INTEGERRIMUS WHOLE; EHRENDORFERIA CHRYSANTHA WHOLE; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; MALUS SYLVESTRIS FLOWER; MIMULUS RINGENS WHOLE; PINUS SYLVESTRIS FLOWERING TOP; SALIX ALBA FLOWERING TOP; STRYCHNOS IGNATII SEED; VERBASCUM DENSIFLORUM FLOWER
Active strength
12; 15; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15; 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
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
F08
Brand name suffix
FRGV
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PINUS SYLVESTRIS FLOWERING TOP12 [hp_C]/mL
SALIX ALBA FLOWERING TOP15 [hp_C]/mL
STRYCHNOS IGNATII SEED12 [hp_C]/mL
VERBASCUM DENSIFLORUM FLOWER12 [hp_C]/mL
AGASTACHE URTICIFOLIA WHOLE12 [hp_C]/mL
MIMULUS RINGENS WHOLE12 [hp_C]/mL
MALUS SYLVESTRIS FLOWER12 [hp_C]/mL
ARNICA MONTANA12 [hp_C]/mL
ARNICA MONTANA FLOWER12 [hp_C]/mL
CEANOTHUS INTEGERRIMUS WHOLE12 [hp_C]/mL
ILEX AQUIFOLIUM FLOWERING TOP12 [hp_C]/mL
FAGUS SYLVATICA FLOWERING TOP15 [hp_C]/mL
EHRENDORFERIA CHRYSANTHA WHOLE12 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2HEM73YI9IInternal UNII lookup
XBP5X7E70RInternal UNII lookup
1NM3M2487KInternal UNII lookup
N7FC535Q3RInternal UNII lookup
8A94843BM7Internal UNII lookup
W4KH5N2DCKInternal UNII lookup
6ZJ8N1924ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
OZ0E5Y15PZInternal UNII lookup
N76K76PTFUInternal UNII lookup
5ENR9SAN1WInternal UNII lookup
21AF0IHY5UInternal UNII lookup
68HKD4QMJRInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc91d5bd-fa6e-8245-e053-2995a90a3e8cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0608-1F08FRGV30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0608F08 FRGV (ALLEGHENY MONKEYFLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS, EHRENDORFERIA CHRYSANTHA, FAGUS SYLVATICA FLOWER, IGNATIA AMARA, ILEX AQUIFOLIUM FLOWER, MALUS SYLVESTRIS FLOWER, MULLEIN FLOWER, NETTLELEAF GIANT HYSSOP, PINUS SYLVESTRIS FLOWER, SALIX ALBA FLOWER) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bc91d5bd-fa6e-8245-e053-2995a90a3e8c.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
F08 FRGVALLEGHENY MONKEYFLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS, EHRENDORFERIA CHRYSANTHA, FAGUS SYLVATICA FLOWER, IGNATIA AMARA, ILEX AQUIFOLIUM FLOWER, MALUS SYLVESTRIS FLOWER, MULLEIN FLOWER, NETTLELEAF GIANT HYSSOP, PINUS SYLVESTRIS FLOWER, SALIX ALBA FLOWERApex Energetics Inc.bc91d5bd-fa6e-8245-e053-2995a90a3e8c2024-01-08WarningsExact identifier
ndc (product): 63479-0608

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0608-16347906080130 mL in 1 BOTTLE, GLASS (63479-0608-1) 30 ml1996-03-120000-00-00NoNoCurrent