FDA.reportPublic FDA data

Snore Soothe

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:05

Label at a glance#

ProductSnore Soothe
Active ingredientHistamine Dihydrochloride, Canis Lupus Familiaris Milk, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Camphor (natural), Helianthemum Canadense, Drosera Rotundifolia Flowering Top, Calcium Sulfide, Goldenseal, Strychnos Ignatii Seed, Iodine, Potassium Dichromate, Potassium Iodide, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Schoenocaulon Officinale Seed, Silicon Dioxide, Lobaria Pulmonaria, Sulfur, Teucrium Marum, Verbascum Thapsus, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Snore - Soothe  Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

DOSAGE & ADMINISTRATION SECTION

ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Histaminum hydrochloricum 15x, Lac caninum 15x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Camphora 10x, Cistus canadensis 10x, Drosera 10x, Hepar sulph.calc. 10x, Hydrastis 10x, Ignatia 10x, Iodium 10x, Kali bic. 10x, Kali iod. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Sabadilla 10x, Silicea 10x, Sticta 10x, Sulphur 10x, Teucrium marum 10x, Verbascum 10x, Echinacea 3x.

OTC - PURPOSE SECTION

 Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package label
Package 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2306-02020-01-31C16284748780-19d75b9d0-66f7-f424-e053-dadaa90a57ceSnore - Soothe
55714-2306-12020-01-31C16284748780-19d75b9d0-66f7-f424-e053-dadaa90a57ceSnore - Soothe
55714-2306-22020-01-31C16284748780-19d75b9d0-66f7-f424-e053-dadaa90a57ceSnore - Soothe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2306-0Snore Soothe.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-2306-1Snore Soothe29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2306-2Snore Soothe59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2306SNORE SOOTHE (HISTAMINUM HYDROCHLORICUM LACCANINUM, ARSENICUM ALB., BELLADONNA BRYONIA,CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPH.CALC., HYDRASTIS, IGNATIA, IODIUM, KALI BIC.,KALI IOD., NUX VOM., PHOSPHORUS, PULSATILLA,SABADILLA, SILICEA, STICTA, SULPHUR, TEUCRIUMMARUM, VERBASCUM, ECHINACEA.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20121031_c57af52e-84a6-b9bb-957b-6c2d5998e794.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Camphor (natural)ACTIVE INGREDIENTN20HL7Q9411
Canis Lupus Familiaris MilkACTIVE INGREDIENTG39P120JQT1
Drosera Rotundifolia Flowering TopACTIVE INGREDIENT75O014T1HG1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Helianthemum CanadenseACTIVE INGREDIENT46G3W789Q31
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U1
IodineACTIVE INGREDIENT9679TC07X41
Lobaria PulmonariaACTIVE INGREDIENTD1YM0P5Z2T1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Potassium IodideACTIVE INGREDIENT1C4QK22F9J1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Schoenocaulon Officinale SeedACTIVE INGREDIENT6NAF1689IO1
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
SulfurACTIVE INGREDIENT70FD1KFU701
Teucrium MarumACTIVE INGREDIENT10464S0TAA1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Camphor (natural)ACTIVE MOIETYN20HL7Q9411
Canis Lupus Familiaris MilkACTIVE MOIETYG39P120JQT1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Drosera Rotundifolia Flowering TopACTIVE MOIETY75O014T1HG1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Helianthemum CanadenseACTIVE MOIETY46G3W789Q31
HistamineACTIVE MOIETY820484N8I31
Iodide IonACTIVE MOIETY09G4I6V86Q1
IodineACTIVE MOIETY9679TC07X41
Lobaria PulmonariaACTIVE MOIETYD1YM0P5Z2T1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Schoenocaulon Officinale SeedACTIVE MOIETY6NAF1689IO1
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
SulfurACTIVE MOIETY70FD1KFU701
Teucrium MarumACTIVE MOIETY10464S0TAA1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-230655714-2306-1, 55714-2306-2, 55714-2306-0

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
Histamine Dihydrochloride3POA0Q644UACTIB
Canis Lupus Familiaris MilkG39P120JQTACTIB
Arsenic TrioxideS7V92P67HOACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Camphor (natural)N20HL7Q941ACTIB
Helianthemum Canadense46G3W789Q3ACTIB
Drosera Rotundifolia Flowering Top75O014T1HGACTIB
Calcium Sulfide1MBW07J51QACTIB
GoldensealZW3Z11D0JVACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Iodine9679TC07X4ACTIB
Potassium DichromateT4423S18FMACTIB
Potassium Iodide1C4QK22F9JACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Schoenocaulon Officinale Seed6NAF1689IOACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Lobaria PulmonariaD1YM0P5Z2TACTIB
Sulfur70FD1KFU70ACTIB
Teucrium Marum10464S0TAAACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
8aa7f69b-a7be-de1a-d092-2a9dd6c184cfc57af52e-84a6-b9bb-957b-6c2d5998e7942011-03-01WarningsExact identifier
spl id: 8aa7f69b-a7be-de1a-d092-2a9dd6c184cf
spl set id: c57af52e-84a6-b9bb-957b-6c2d5998e794

Reported adverse events (FAERS/openFDA)#

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