Snore-Soothe

Product NDC
55714-2591
11-digit product format
557142591
Labeler code
55714
Product ID
55714-2591_140a19fd-51d7-c90b-e063-6394a90a1745
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-19
Substance
ANEMONE PULSATILLA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAMPHOR (NATURAL); CANIS LUPUS FAMILIARIS MILK; DROSERA ANGLICA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; HELIANTHEMUM CANADENSE; HISTAMINE DIHYDROCHLORIDE; IODINE; LOBARIA PULMONARIA; PHOSPHORUS; POTASSIUM DICHROMATE; POTASSIUM IODIDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Snore-Soothe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA, UNSPECIFIED15 [hp_X]/mL
HELIANTHEMUM CANADENSE15 [hp_X]/mL
DROSERA ANGLICA15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
GOLDENSEAL15 [hp_X]/mL
STRYCHNOS IGNATII SEED15 [hp_X]/mL
IODINE15 [hp_X]/mL
POTASSIUM DICHROMATE15 [hp_X]/mL
POTASSIUM IODIDE6 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
LOBARIA PULMONARIA15 [hp_X]/mL
SULFUR15 [hp_X]/mL
TEUCRIUM MARUM15 [hp_X]/mL
VERBASCUM THAPSUS15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE15 [hp_X]/mL
CANIS LUPUS FAMILIARIS MILK15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CAMPHOR (NATURAL)15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4N9P6CC1DXInternal UNII lookup
46G3W789Q3Internal UNII lookup
J61BY05EGYInternal UNII lookup
1MBW07J51QInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
1NM3M2487KInternal UNII lookup
9679TC07X4Internal UNII lookup
T4423S18FMInternal UNII lookup
1C4QK22F9JInternal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal UNII lookup
6NAF1689IOInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
D1YM0P5Z2TInternal UNII lookup
70FD1KFU70Internal UNII lookup
10464S0TAAInternal UNII lookup
C9TD27U172Internal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
3POA0Q644UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
140a0bcf-82b3-c430-e063-6294a90ad38fAvailable 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
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

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 (product): 55714-2591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2591-15571425910130 mL in 1 BOTTLE, GLASS (55714-2591-1) 30 ml2024-03-19NoNoCurrent