FDA.reportPublic FDA data

NativeRemedies® Good Night Sleep Oral Spray

Manufacturer
Silver Star Brands | OHM Pharma
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:29:58

Label at a glance#

ProductGood Night Sleep
Active ingredientSTRYCHNOS IGNATII WHOLE, COFFEA ARABICA FRUIT, ANEMONE PATENS WHOLE, VALERIANA OFFICINALIS WHOLE, AVENA SATIVA LEAF, PASSIFLORA INCARNATA FLOWER, ANAMIRTA COCCULUS SEED, DELPHINIUM STAPHISAGRIA SEED, ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM FLOWER, HYOSCYAMUS NIGER
Label structure11 sections

Indications and uses

Uses*: Temporarily relieves symptoms of occasional sleeplessness. *This statement has not been evaluated by the food and Drug Administration. This product is not inteded to diagnose, treat, cure or prevent any disease.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. Children 2-12: 2 sprays, 3 times per day. Use additionally as needed, up to 6 times per day.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volumes of each ingrediet in 10X, 30X, 1LM potencies. Aconitum nap, Aesculus hipp, flos, Avena, Cocculus, Coffea cruda, Hysocyamus, Ignatia, Passiflora, Pusatilla nutt, Staphysag, Valeriana.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Temporarily relieves symptoms of occasional sleeplessness.

*This statement has not been evaluated by the food and Drug Administration. This product is not inteded to diagnose, treat, cure or prevent any disease.

Warnings

WARNINGS SECTION

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Adults and Children 12+: 3 sprays, 3 times per day. Children 2-12: 2 sprays, 3 times per day. Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. use only if saftey seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified water, carya ovata bark extract (hickory), citrust extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - PURPOSE SECTION

Temporarily relieves symptoms of occasional sleeplessness

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label imageLabel image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-346-022023-03-06C16284748780-1d6a99b39-d446-a426-e053-dadaa90af4c2NativeRemedies® Good Night Sleep Oral Spray
68703-346-022022-01-28C16284748780-1d6a99b39-d446-a426-e053-dadaa90af4c2NativeRemedies® Good Night Sleep Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-346-02Good Night Sleep59 mL in 1 BOTTLE, SPRAYSPRAY596

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-346GOOD NIGHT SLEEP (ACONITUM NAP,AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAG, VALERIANA) SPRAY [SILVER STAR BRANDS]6Current NDC, Legacy NDC, 1 package rows20250103_9d5e8a6b-b908-26ee-e053-2995a90ae8c5.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-34668703-346-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
STRYCHNOS IGNATII WHOLE6YSJ329777ACTIB
COFFEA ARABICA FRUITHOX6BEK27QACTIB
WATER059QF0KO0RIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
CARYA OVATA BARKX765CF609LIACT
ANEMONE PATENS WHOLE4M1169RWJDACTIB
VALERIANA OFFICINALIS WHOLEFP6O7F1X9RACTIB
AVENA SATIVA LEAF206PI19V7RACTIB
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZACTIB
GLUCOSYL STEVIOLTKD5UC898QIACT
ANAMIRTA COCCULUS SEED810258W28UACTIB
BENZYLPENICILLOYL POLYLYSINE76479814OYIACT
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
AESCULUS HIPPOCASTANUM FLOWERKK0Z92II8MACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
Good Night SleepACONITUM NAP,AESCULUS HIPP, FLOS, AVENA, COCCULUS, COFFEA CRUDA, HYOSCYAMUS, IGNATIA, PASSIFLORA, PULSATILLA NUTT, STAPHYSAG, VALERIANASilver Star Brands9d5e8a6b-b908-26ee-e053-2995a90ae8c52025-01-01WarningsExact identifier
ndc (package): 68703-346-02
ndc (product): 68703-346
ndc11 (package): 68703034602
spl id: 2ab18656-b091-9a48-e063-6294a90a8f25
spl set id: 9d5e8a6b-b908-26ee-e053-2995a90ae8c5

Reported adverse events (FAERS/openFDA)#

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