FDA.reportPublic FDA data

B20

Product NDC
63479-0220
11-digit product format
634790220
Labeler code
63479
Product ID
63479-0220_0e8b3606-7e0b-af78-e063-6294a90afbd2
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS
Dosage form
CREAM
Route
TOPICAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1994-08-30
Substance
ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS WHOLE; 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; MENTHA PIPERITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PLANTAGO MAJOR; PRUNUS CERASIFERA FLOWER; RHODODENDRON TOMENTOSUM LEAFY TWIG; SOLANUM DULCAMARA WHOLE; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT; VERBASCUM THAPSUS
Active strength
3; 30; 12; 30; 15; 30; 12; 12; 9; 8; 30; 6; 6; 6; 8; 15; 3; 30; 12; 6; 30; 8; 1; 30; 1; 30; 1; 8; 9; 12; 30; 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; [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; [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
B20
Brand name suffix
ACUTE RESCUE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPERICUM PERFORATUM3 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER30 [hp_X]/mL
MENTHA PIPERITA12 [hp_X]/mL
APIS MELLIFERA30 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP15 [hp_X]/mL
ECHINACEA PURPUREA30 [hp_X]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG12 [hp_X]/mL
COMFREY ROOT12 [hp_X]/mL
VERATRUM ALBUM ROOT9 [hp_X]/mL
FERROSOFERRIC PHOSPHATE8 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK30 [hp_X]/mL
BELLIS PERENNIS6 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
PLANTAGO MAJOR6 [hp_X]/mL
ARNICA MONTANA8 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
MATRICARIA CHAMOMILLA30 [hp_X]/mL
CLEMATIS VITALBA FLOWER12 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]/mL
SOLANUM DULCAMARA WHOLE30 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA8 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE1 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF1 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER30 [hp_X]/mL
SULFUR1 [hp_X]/mL
VERBASCUM THAPSUS8 [hp_X]/mL
ACONITUM NAPELLUS WHOLE9 [hp_C]/mL
PRUNUS CERASIFERA FLOWER12 [hp_X]/mL
ACHILLEA MILLEFOLIUM30 [hp_X]/mL
ARSENIC TRIOXIDE1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 32 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XK4IUX8MNBInternal UNII lookup
AJU5O1A5ZVInternal UNII lookup
79M2M2UDA9Internal UNII lookup
7S82P3R43ZInternal UNII lookup
1W0775VX6EInternal UNII lookup
QI7G114Y98Internal UNII lookup
877L01IZ0PInternal UNII lookup
M9VVZ08EKQInternal UNII lookup
QNS6W5US1ZInternal UNII lookup
91GQH8I5F7Internal UNII lookup
T7S323PKJSInternal UNII lookup
2HU33I03UYInternal UNII lookup
T7J046YI2BInternal UNII lookup
W2469WNO6UInternal UNII lookup
O80TY208ZWInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
18E7415PXQInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
7SCP4N87CIInternal UNII lookup
23H32AOH17Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bccc6476-4987-b1a0-e053-2995a90a5a02Available 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
63479-0220-1B20ACUTE RESCUE50 mL in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0220B20 ACUTE RESCUE (ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS) CREAM [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bccc6476-4987-b1a0-e053-2995a90a5a02.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
B20 ACUTE RESCUEACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUSApex Energetics Inc.bccc6476-4987-b1a0-e053-2995a90a5a022024-01-09WarningsExact identifier
ndc (product): 63479-0220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63479-0220-16347902200150 mL in 1 BOTTLE, PUMP (63479-0220-1) 50 ml1994-08-300000-00-00NoNoCurrent