FDA.reportPublic FDA data

SleepCalm

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:32:43

Label at a glance#

ProductSleepCalm
Active ingredientHYOSCYAMUS NIGER, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM, NUTMEG
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients** (in each tablet)

Hyoscyamus niger 3C HPUS (0.63 mg) (contains less than 10 -9 mg alkaloids)
Nux moschata 4C HPUS (0.63 mg)
Passiflora incarnata 3X HPUS (0.63 mg)
Stramonium 6X HPUS (0.63 mg) (contains less than 10- 8 mg alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Hyoscyamus niger 3C HPUS (0.63 mg) ... Relieves restless sleep associated with nervousness

Nux moschata 4C HPUS (0.63 mg) ... Relieves restless sleep
Passiflora incarnata 3X HPUS (0.63 mg) ... Relieves sleeplessness associated with worries and exhaustion
Stramonium 6X HPUS (0.63 mg) ... Relieves sleeplessness with intermittent awakening

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves: occasional sleeplessness, restless sleep, intermittent awakening

helps reduce difficulty falling asleep due to: nervousness, worries

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks or worsens. Insomnia may be a symptom of a serious underlying illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth at bedtime.

Children under 12 of age: Ask a doctor.

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 oF (30 oC)

Contains 20 meltaway tablets

Contains 60 meltaway tablets

Contains 100 meltaway tablets

Contains 120 meltaway tablets

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Calms Restless Mind*

No Known Drug Interactions

Non-habit forming

No artificial sweetners or flavors

Gluten-free

Melatonin-Free

Sleep Relief*

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate

OTC - QUESTIONS SECTION

BoironUSA.com

Info@boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1KNE1KNE

hwbhwb

1hwc1hwc

LABELLABEL

hwehwe

gubgub

1wd1wd

11201120

LABELSLABELS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9310-042023-01-31C16284748780-1f386c64a-35d8-0266-e053-dadaa90a7c1aSleepCalm
0220-9310-292023-01-31C16284748780-1f386c64a-35d8-0266-e053-dadaa90a7c1aSleepCalm
0220-9310-912023-01-31C16284748780-1f386c64a-35d8-0266-e053-dadaa90a7c1aSleepCalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9310-04SleepCalm1 in 1 PACKAGETABLET16
0220-9310-04SleepCalm60 in 1 BLISTER PACKTABLET606
0220-9310-29SleepCalm120 in 1 BLISTER PACKTABLET1206
0220-9310-29SleepCalm1 in 1 PACKAGETABLET16
0220-9310-91SleepCalm20 in 1 BLISTER PACKTABLET206
0220-9310-91SleepCalm1 in 1 PACKAGETABLET16
0220-9310-92SleepCalm20 in 1 BLISTER PACKTABLET206
0220-9310-92SleepCalm5 in 1 PACKAGETABLET56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9310SLEEPCALM (HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM) TABLET [LABORATOIRES BOIRON]6Current NDC, Legacy NDC, 8 package rows20250323_a1db8417-baea-6914-e053-2a95a90a2fd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-9310-04EA - Each0220-9310b56ffcfa-68d5-4ba2-aa59-fe2a5b5fa02612021-02-05

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93100220-9310-04, 0220-9310-29, 0220-9310-91, 0220-9310-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYOSCYAMUS NIGER4WRK2153H3ACTIB
PASSIFLORA INCARNATA TOPCLF5YFS11OACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
NUTMEGAEE24M3MQ9ACTIB

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
SleepCalmHYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUMLaboratoires Boirona1db8417-baea-6914-e053-2a95a90a2fd32025-03-21Exact identifier
ndc (package): 0220-9310-04
ndc (package): 0220-9310-92
ndc (package): 0220-9310-29
ndc (package): 0220-9310-91
ndc (product): 0220-9310
ndc11 (package): 00220931092
ndc11 (package): 00220931004
ndc11 (package): 00220931091
ndc11 (package): 00220931029
spl id: 30dd55c3-2031-ce2f-e063-6294a90a3f1f
spl set id: a1db8417-baea-6914-e053-2a95a90a2fd3

Reported adverse events (FAERS/openFDA)#

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