Snore-Soothe

Product NDC
55714-2518
11-digit product format
557142518
Labeler code
55714
Product ID
55714-2518_9cc3322f-890e-ed71-e053-2a95a90a323c
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
2019-01-01
Marketing end
0000-00-00
Substance
ECHINACEA, 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)
Active strength
6 [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
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55714-2518DDiscontinued by firm2026-10-05
excluded packagepackage55714-251855714-2518-1DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55714-2518-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55714-2518-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55714-2518-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55714-2518-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55714-2518-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55714-2518-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2518-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2518-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2518-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2518-12025-11-26C16284748780-12cef2736-6103-d83d-e063-dadaa90ab31fSnore 2518L
55714-2518-12025-01-30C16284748780-12cef2736-6103-d83d-e063-dadaa90ab31fSnore 2518L

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2518SNORE-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.]1Legacy NDC20200124_9cc31ba8-5325-60e6-e053-2a95a90a1a9d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2518-15571425180130 mL in 1 BOTTLE, GLASS (55714-2518-1) 30 ml2019-01-010000-00-00NoNoCurrent