FDA.reportPublic FDA data

Panic Button

Product NDC
55714-2494
Requested package NDC
55714-2494-1
11-digit product format
557142494
Labeler code
55714
Product ID
55714-2494_2d952971-e31c-674d-e063-6294a90abb16
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana.
Dosage form
PELLET
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-08-01
Substance
ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACTIC ACID, L-; MATRICARIA CHAMOMILLA; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VALERIAN; VERATRUM ALBUM ROOT
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panic ButtonACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9b3f50f3-1397-da75-e053-2995a90a340c2025-02-07WarningsExact identifier
ndc (package): 55714-2494-1
ndc (product): 55714-2494
ndc11 (package): 55714249401

Additional Listing Data#

Finished product
Yes
Brand name base
Panic Button
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS15 [hp_X]/g
APIS MELLIFERA15 [hp_X]/g
ARNICA MONTANA15 [hp_X]/g
ARSENIC TRIOXIDE15 [hp_X]/g
ATROPA BELLADONNA15 [hp_X]/g
BELLIS PERENNIS15 [hp_X]/g
BRYONIA ALBA ROOT15 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]/g
MATRICARIA CHAMOMILLA15 [hp_X]/g
HELIANTHEMUM CANADENSE15 [hp_X]/g
FERROSOFERRIC PHOSPHATE15 [hp_X]/g
HISTAMINE DIHYDROCHLORIDE15 [hp_X]/g
HYPERICUM PERFORATUM15 [hp_X]/g
STRYCHNOS IGNATII SEED15 [hp_X]/g
DAPHNE MEZEREUM BARK15 [hp_X]/g
ORNITHOGALUM UMBELLATUM15 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/g
PASSIFLORA INCARNATA FLOWERING TOP15 [hp_X]/g
PHOSPHORUS15 [hp_X]/g
PRUNUS SPINOSA FLOWER BUD15 [hp_X]/g
LACTIC ACID, L-15 [hp_X]/g
SULFUR15 [hp_X]/g
VERATRUM ALBUM ROOT6 [hp_X]/g
VALERIAN15 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 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
46G3W789Q3Internal UNII lookup
91GQH8I5F7Internal UNII lookup
3POA0Q644UInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
1NM3M2487KInternal UNII lookup
X2N6E405GVInternal UNII lookup
9NS3M2Y78SInternal UNII lookup
6IO182RP7AInternal UNII lookup
CLF5YFS11OInternal UNII lookup
27YLU75U4WInternal UNII lookup
53Y84VPS2WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b3f50f3-1397-da75-e053-2995a90a340cAvailable 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
55714-2494-1Panic Button28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2494PANIC BUTTON (ACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250210_9b3f50f3-1397-da75-e053-2995a90a340c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2494-15571424940128 g in 1 BOTTLE, GLASS (55714-2494-1) 28 g2019-08-010000-00-00NoNoCurrent