FDA.reportPublic FDA data

B21

Product NDC
63479-0221
11-digit product format
634790221
Labeler code
63479
Product ID
63479-0221_4742a0ff-3052-b425-e063-6294a90a556e
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUS
Dosage form
SPRAY
Route
SUBLINGUAL
Labeler
Apex Energetics Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-05-15
Substance
APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; PRUNUS CERASIFERA FLOWER; CITRULLUS COLOCYNTHIS FRUIT PULP; ECHINACEA PURPUREA; ECHINACEA ANGUSTIFOLIA; LEDUM PALUSTRE TWIG; MENTHA PIPERITA; PLANTAGO MAJOR; ORNITHOGALUM UMBELLATUM FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; HELIANTHEMUM NUMMULARIUM FLOWER; HISTAMINE DIHYDROCHLORIDE; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT; VERBASCUM THAPSUS; ARSENIC TRIOXIDE; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; CLEMATIS VITALBA FLOWER; SOLANUM DULCAMARA WHOLE
Active strength
12; 30; 30; 12; 30; 8; 6; 6; 1; 1; 1; 30; 12; 30; 12; 9; 6; 30; 1; 15; 12; 9; 8; 8; 15; 3; 6; 30; 3; 30; 30; 8 [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; [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
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
B21
Brand name suffix
ACUTE RESCUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA12 [hp_X]/mL
ARNICA MONTANA30 [hp_X]/mL
ATROPA BELLADONNA30 [hp_X]/mL
BRYONIA ALBA ROOT12 [hp_X]/mL
PRUNUS CERASIFERA FLOWER30 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP8 [hp_X]/mL
ECHINACEA PURPUREA6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA6 [hp_X]/mL
LEDUM PALUSTRE TWIG1 [hp_X]/mL
MENTHA PIPERITA1 [hp_X]/mL
PLANTAGO MAJOR1 [hp_X]/mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP30 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF12 [hp_X]/mL
HELIANTHEMUM NUMMULARIUM FLOWER30 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
SULFUR9 [hp_C]/mL
COMFREY ROOT6 [hp_X]/mL
VERATRUM ALBUM ROOT30 [hp_X]/mL
VERBASCUM THAPSUS1 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BELLIS PERENNIS12 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP9 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE8 [hp_X]/mL
EUPATORIUM PERFOLIATUM FLOWERING TOP8 [hp_X]/mL
FERROSOFERRIC PHOSPHATE15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/mL
HYPERICUM PERFORATUM6 [hp_X]/mL
IMPATIENS GLANDULIFERA FLOWER30 [hp_X]/mL
ACHILLEA MILLEFOLIUM3 [hp_X]/mL
ACONITUM NAPELLUS30 [hp_X]/mL
CLEMATIS VITALBA FLOWER30 [hp_X]/mL
SOLANUM DULCAMARA WHOLE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 32 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
0KD7R09EASInternal UNII lookup
23H32AOH17Internal UNII lookup
QI7G114Y98Internal UNII lookup
VB06AV5US8Internal UNII lookup
877L01IZ0PInternal UNII lookup
79M2M2UDA9Internal UNII lookup
W2469WNO6UInternal UNII lookup
CZD6M4PY4BInternal UNII lookup
6IO182RP7AInternal UNII lookup
51BRR32WPPInternal UNII lookup
3POA0Q644UInternal UNII lookup
70FD1KFU70Internal UNII lookup
M9VVZ08EKQInternal UNII lookup
QNS6W5US1ZInternal UNII lookup
C9TD27U172Internal UNII lookup
S7V92P67HOInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16c76a4d-7085-f8f5-e063-6294a90a5b37Available 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
63479-0221-1B21ACUTE RESCUE60 mL in 1 BOTTLE, SPRAYSPRAY603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0221B21 ACUTE RESCUE (ACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUS) SPRAY [APEX ENERGETICS INC.]2Current NDC, 1 package rows20250110_16c76a4d-7085-f8f5-e063-6294a90a5b37.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
B21 ACUTE RESCUEACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUSApex Energetics Inc.16c76a4d-7085-f8f5-e063-6294a90a5b372025-12-31WarningsExact identifier
ndc (product): 63479-0221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63479-0221-16347902210160 mL in 1 BOTTLE, SPRAY (63479-0221-1) 60 ml2024-05-15NoNoCurrent