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
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; LEDUM PALUSTRE TWIG; MATRICARIA CHAMOMILLA WHOLE; MENTHA PIPERITA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PLANTAGO MAJOR; PRUNUS CERASIFERA FLOWER; 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; 1; 8; 1; 30; 1; 30; 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
B21
Brand name suffix
ACUTE RESCUE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FXJ6SW4PK, U0NQ8555JD, 7S82P3R43Z, O80TY208ZW, S7V92P67HO, WQZ3G9PF0H, 2HU33I03UY, T7J046YI2B, 18E7415PXQ, 23H32AOH17, 7SCP4N87CI, M9VVZ08EKQ, VB06AV5US8, QI7G114Y98, 1W0775VX6E, 91GQH8I5F7, T7S323PKJS, 51BRR32WPP, 3POA0Q644U, XK4IUX8MNB

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

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