B01

Product NDC
63479-0201
11-digit product format
634790201
Labeler code
63479
Product ID
63479-0201_0e76a879-b2c6-dcc6-e063-6294a90ac60e
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1988-08-15
Substance
ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; CLEMATIS VITALBA FLOWER; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHEMUM NUMMULARIUM FLOWER; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MATRICARIA CHAMOMILLA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; SOLANUM DULCAMARA WHOLE; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT
Active strength
3; 30; 12; 30; 15; 30; 12; 12; 9; 8; 30; 3; 6; 6; 8; 15; 3; 30; 12; 6; 30; 8; 30; 30; 8; 9; 12; 30 [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom 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
B01
Brand name suffix
ACUTE RESCUE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS3 [hp_X]/mL
APIS MELLIFERA30 [hp_X]/mL
ARNICA MONTANA12 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BELLIS PERENNIS30 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP12 [hp_X]/mL
MATRICARIA CHAMOMILLA9 [hp_X]/mL
PRUNUS CERASIFERA FLOWER8 [hp_X]/mL
CLEMATIS VITALBA FLOWER30 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]/mL
SOLANUM DULCAMARA WHOLE6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA6 [hp_X]/mL
ECHINACEA PURPUREA8 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]/mL
FERROSOFERRIC PHOSPHATE3 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK30 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
HYPERICUM PERFORATUM6 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER30 [hp_X]/mL
ACHILLEA MILLEFOLIUM8 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF30 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER30 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP8 [hp_X]/mL
SULFUR9 [hp_C]/mL
COMFREY ROOT12 [hp_X]/mL
VERATRUM ALBUM ROOT30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 28 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
7S82P3R43ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
2HU33I03UYInternal UNII lookup
T7J046YI2BInternal UNII lookup
18E7415PXQInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
0KD7R09EASInternal UNII lookup
7SCP4N87CIInternal UNII lookup
23H32AOH17Internal UNII lookup
G72JA9DHK5Internal UNII lookup
VB06AV5US8Internal UNII lookup
QI7G114Y98Internal UNII lookup
1W0775VX6EInternal UNII lookup
91GQH8I5F7Internal UNII lookup
T7S323PKJSInternal UNII lookup
3POA0Q644UInternal UNII lookup
XK4IUX8MNBInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ce96ca9-8964-4b60-9d99-bf01d3d1cb43Available 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
63479-0201-1B01ACUTE RESCUE30 mL in 1 BOTTLE, GLASSSOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0201B01 ACUTE RESCUE (ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM) SOLUTION [APEX ENERGETICS INC.]4Current NDC, Legacy NDC, 1 package rows20240110_4ce96ca9-8964-4b60-9d99-bf01d3d1cb43.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
B01 ACUTE RESCUEACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUMApex Energetics Inc.4ce96ca9-8964-4b60-9d99-bf01d3d1cb432024-01-08WarningsExact identifier
ndc (product): 63479-0201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0201-16347902010130 mL in 1 BOTTLE, GLASS (63479-0201-1) 30 ml1988-08-150000-00-00NoNoCurrent