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
HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; MENTHA PIPERITA; APIS MELLIFERA; EUPATORIUM PERFOLIATUM FLOWERING TOP; ECHINACEA PURPUREA; RHODODENDRON TOMENTOSUM LEAFY TWIG; COMFREY ROOT; VERATRUM ALBUM ROOT; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BELLIS PERENNIS; BRYONIA ALBA ROOT; PLANTAGO MAJOR; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; CLEMATIS VITALBA FLOWER; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA WHOLE; ECHINACEA ANGUSTIFOLIA; HISTAMINE DIHYDROCHLORIDE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; HELIANTHEMUM NUMMULARIUM FLOWER; SULFUR; VERBASCUM THAPSUS; ACONITUM NAPELLUS WHOLE; PRUNUS CERASIFERA FLOWER; ACHILLEA MILLEFOLIUM; ARSENIC TRIOXIDE
Active strength
6; 30; 1; 12; 8; 6; 1; 6; 30; 15; 3; 12; 12; 1; 30; 30; 9; 8; 30; 8; 8; 6; 12; 30; 12; 30; 9; 1; 30; 30; 3; 15 [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; [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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
B20
Brand name suffix
ACUTE RESCUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYPERICUM PERFORATUM6 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER30 [hp_X]/mL
MENTHA PIPERITA1 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP8 [hp_X]/mL
ECHINACEA PURPUREA6 [hp_X]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG1 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
VERATRUM ALBUM ROOT30 [hp_X]/mL
FERROSOFERRIC PHOSPHATE15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/mL
BELLIS PERENNIS12 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
PLANTAGO MAJOR1 [hp_X]/mL
ARNICA MONTANA30 [hp_X]/mL
ATROPA BELLADONNA30 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP9 [hp_X]/mL
MATRICARIA CHAMOMILLA8 [hp_X]/mL
CLEMATIS VITALBA FLOWER30 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP8 [hp_X]/mL
SOLANUM DULCAMARA WHOLE8 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA6 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER30 [hp_X]/mL
SULFUR9 [hp_C]/mL
VERBASCUM THAPSUS1 [hp_X]/mL
ACONITUM NAPELLUS WHOLE30 [hp_X]/mL
PRUNUS CERASIFERA FLOWER30 [hp_X]/mL
ACHILLEA MILLEFOLIUM3 [hp_X]/mL
ARSENIC TRIOXIDE15 [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