FDA.reportPublic FDA data

Dust-Mold-Dander

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:49

Label at a glance#

ProductDust-Mold-Dander
Active ingredientHOUSE DUST, IRIS VERSICOLOR ROOT, ANTIMONY TRISULFIDE, APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BLATTA ORIENTALIS, BROMINE, BRYONIA ALBA ROOT, CANDIDA ALBICANS, CENTAUREA BENEDICTA, FELIS CATUS HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, CANIS LUPUS FAMILIARIS HAIR, HISTAMINE DIHYDROCHLORIDE, IPECAC, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PODOPHYLLUM, TOXICODENDRON PUBESCENS LEAF, CLAVICEPS PURPUREA SCLEROTIUM, SILICON DIOXIDE, USTILAGO MAYDIS, SACCHAROMYCES CEREVISIAE, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations,

DOSAGE & ADMINISTRATION SECTION

Ages 12 and up, take 6 pelletsby mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Apis mellifica 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Blatta orientalis 15x, Bromium 15x, Bryonia 15x, Candida albicans 15x, Carduus benedictus 15x, Cat hair 15x, Chelidonium majus 15x, Cinchona officinalis 15x, Dog hair 15x, Histaminum hydrochloricum 15x, House dust 15x, Ipecacuanha 15x, Lycopodium clavatum 15x, Nux vomica 15x, Podophyllum peltatum 15x, Rhus toxicodendron 15x, Secale cornutum 15x, Silicea 15x, Ustilago maidis 15x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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
55714-2423-1Dust-Mold-Dander28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2423DUST-MOLD-DANDER (IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250209_9bb84bae-9019-ed76-e053-2a95a90a5c3e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-242355714-2423-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOUSE DUSTEYO007VX98ACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BLATTA ORIENTALIS535787266DACTIB
BROMINESBV4XY874GACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
FELIS CATUS HAIR1564HD0N96ACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CANIS LUPUS FAMILIARIS HAIR05S7L91ZTRACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
IPECAC62I3C8233LACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PODOPHYLLUM2S713A4VP3ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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
Dust-Mold-DanderIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.Newton Laboratories, Inc.9bb84bae-9019-ed76-e053-2a95a90a5c3e2025-02-06WarningsExact identifier
ndc (package): 55714-2423-1
ndc (product): 55714-2423
ndc11 (package): 55714242301
spl id: 2d8191ac-9462-9feb-e063-6394a90a1cec
spl set id: 9bb84bae-9019-ed76-e053-2a95a90a5c3e

Reported adverse events (FAERS/openFDA)#

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