FDA.reportPublic FDA data

Snore-Soothe

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:25

Label at a glance#

ProductSnore-Soothe
Active ingredientECHINACEA, UNSPECIFIED, HELIANTHEMUM CANADENSE, DROSERA ANGLICA, CALCIUM SULFIDE, GOLDENSEAL, STRYCHNOS IGNATII SEED, IODINE, POTASSIUM DICHROMATE, POTASSIUM IODIDE, PHOSPHORUS, ANEMONE PULSATILLA, SCHOENOCAULON OFFICINALE SEED, SILICON DIOXIDE, LOBARIA PULMONARIA, SULFUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, HISTAMINE DIHYDROCHLORIDE, CANIS LUPUS FAMILIARIS MILK, STRYCHNOS NUX-VOMICA SEED, BRYONIA ALBA ROOT, CAMPHOR (NATURAL)
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as congestion, constriction, gland swelling, tension and inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cistus canadensis 15x, Drosera 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Ignatia 15x, Iodium 15x, Kali bic. 15x, Kali iod. 15x, Lac can. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Sabadilla 15x, Silicea 15x, Sticta 15x, Sulphur 15x, Teucrium mar. 15x, Verbascum 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as congestion, constriction, gland swelling, tension and inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

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
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2591-1Snore-Soothe30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2591SNORE-SOOTHE (ECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICA) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240321_140a0bcf-82b3-c430-e063-6294a90ad38f.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
55714-259155714-2591-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
DROSERA ANGLICAJ61BY05EGYACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
GOLDENSEALZW3Z11D0JVACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IODINE9679TC07X4ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
SULFUR70FD1KFU70ACTIB
TEUCRIUM MARUM10464S0TAAACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
CANIS LUPUS FAMILIARIS MILKG39P120JQTACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
WATER059QF0KO0RIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB

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
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
ndc (package): 55714-2591-1
ndc (product): 55714-2591
ndc11 (package): 55714259101
spl id: 140a19fd-51d7-c90b-e063-6394a90a1745
spl set id: 140a0bcf-82b3-c430-e063-6294a90ad38f

Reported adverse events (FAERS/openFDA)#

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