FDA.reportPublic FDA data

Sniffles

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:34

Label at a glance#

ProductSniffles
Active ingredientECHINACEA, UNSPECIFIED, STRYCHNOS NUX-VOMICA SEED, AMERICAN GINSENG, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, GAULTHERIA PROCUMBENS TOP, GELSEMIUM SEMPERVIRENS ROOT, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, SAGE, LOBARIA PULMONARIA, THUJA OCCIDENTALIS LEAFY TWIG, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PHOSPHORUS, ACONITUM NAPELLUS
Label structure10 sections

Indications and uses

Formulated for associated symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) as needed or as directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Aconitum napellus 15x, Aralia quinquefolia 15x, Arsenicum album 15x, Bryonia 15x, Euphrasia officinalis 15x, Gaultheria procumbens 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Kali bichromicum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salvia officinalis 15x, Sticta pulmonaria 15x, Thuja occidentalis 15x, Verbascum thapsus 15x, Sinusitisinum 16x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as congestion, runny nose, post-nasal drip, sinus pressure and irritated throat.

INACTIVE INGREDIENT SECTION

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

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

WARNINGS: 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
55714-1529-1Sniffles30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1529SNIFFLES (ECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250129_9db1327c-6746-76cb-e053-2995a90a6e27.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-152955714-1529-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
AMERICAN GINSENG8W75VCV53QACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GAULTHERIA PROCUMBENS TOP830295X963ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
WATER059QF0KO0RIACT
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SAGE065C5D077JACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ALCOHOL3K9958V90MIACT
VERBASCUM THAPSUSC9TD27U172ACTIB
SINUSITISINUMB575563DM5ACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
PHOSPHORUS27YLU75U4WACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB

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
SnifflesECHINACEA, ACONITUM NAPELLUS, ARALIA QUINQUEFOLIA, ARSENICUM ALBUM, BRYONIA, EUPHRASIA OFFICINALIS, GAULTHERIA PROCUMBENS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALVIA OFFICINALIS, STICTA PULMONARIA, THUJA OCCIDENTALIS, VERBASCUM THAPSUS, SINUSITISINUM, INFLUENZINUMNewton Laboratories, Inc.9db1327c-6746-76cb-e053-2995a90a6e272025-01-27WarningsExact identifier
ndc (package): 55714-1529-1
ndc (product): 55714-1529
ndc11 (package): 55714152901
spl id: 2cb88e71-6c27-a2a2-e063-6294a90aa2b2
spl set id: 9db1327c-6746-76cb-e053-2995a90a6e27

Reported adverse events (FAERS/openFDA)#

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