FDA.reportPublic FDA data

SleepCalm

Product NDC
0220-9310
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
DATURA STRAMONIUM; HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP
Active strength
6; 3; 4; 3 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG6W4F0V8Z3, 4WRK2153H3, AEE24M3MQ9, CLF5YFS11O

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9310-04002209310041 BLISTER PACK in 1 PACKAGE (0220-9310-04) / 60 TABLET in 1 BLISTER PACK1 blister pack2020-04-010000-00-00NoNoCurrent
0220-9310-29002209310291 BLISTER PACK in 1 PACKAGE (0220-9310-29) / 120 TABLET in 1 BLISTER PACK1 blister pack2020-12-110000-00-00NoNoCurrent
0220-9310-91002209310911 BLISTER PACK in 1 PACKAGE (0220-9310-91) / 20 TABLET in 1 BLISTER PACK1 blister pack2021-07-120000-00-00NoNoCurrent
0220-9310-92002209310925 BLISTER PACK in 1 PACKAGE (0220-9310-92) / 20 TABLET in 1 BLISTER PACK5 blister pack2025-03-21NoNoCurrent