FDA.reportPublic FDA data

SleepCalm

Product NDC
0220-9310
Requested package NDC
0220-9310-91
11-digit product format
002209310
Labeler code
0220
Product ID
0220-9310_30dd55c3-2031-ce2f-e063-6294a90a3f1f
Type
HUMAN OTC DRUG
Nonproprietary name
HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM
Dosage form
TABLET
Route
ORAL
Labeler
Laboratoires Boiron
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-01
Substance
HYOSCYAMUS NIGER; PASSIFLORA INCARNATA TOP; DATURA STRAMONIUM; NUTMEG
Active strength
3; 3; 6; 4 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], 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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMUS NIGER3 [hp_C]/1
PASSIFLORA INCARNATA TOP3 [hp_X]/1
DATURA STRAMONIUM6 [hp_X]/1
NUTMEG4 [hp_C]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4WRK2153H3Internal UNII lookup
CLF5YFS11OInternal UNII lookup
G6W4F0V8Z3Internal UNII lookup
AEE24M3MQ9Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1db8417-baea-6914-e053-2a95a90a2fd3Available on FDA.report

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 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

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

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): 0220-9310-91
ndc (product): 0220-9310
ndc11 (package): 00220931091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9310-91002209310911 BLISTER PACK in 1 PACKAGE (0220-9310-91) / 20 TABLET in 1 BLISTER PACK1 blister pack2021-07-120000-00-00NoNoCurrent