sleepcalm

Generic: hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium

Labeler: laboratoires boiron
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name sleepcalm
Generic Name hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium
Labeler laboratoires boiron
Dosage Form TABLET
Routes
ORAL
Active Ingredients

datura stramonium 6 [hp_X]/1, hyoscyamus niger 3 [hp_C]/1, nutmeg 4 [hp_C]/1, passiflora incarnata top 3 [hp_X]/1

Manufacturer
Laboratoires Boiron

Identifiers & Regulatory

Product NDC 0220-9310
Product ID 0220-9310_30dd55c3-2031-ce2f-e063-6294a90a3f1f
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2020-04-01

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] plant proteins [cs] dietary proteins [cs] food additives [cs] seed storage proteins [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02209310
Hyphenated Format 0220-9310

Supplemental Identifiers

UNII
G6W4F0V8Z3 4WRK2153H3 AEE24M3MQ9 CLF5YFS11O
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0016962 M0006342 M0008672 M0516536

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sleepcalm (source: ndc)
Generic Name hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 [hp_X]/1
  • 3 [hp_C]/1
  • 4 [hp_C]/1
  • 3 [hp_X]/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 PACKAGE (0220-9310-04) / 60 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 PACKAGE (0220-9310-29) / 120 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 PACKAGE (0220-9310-91) / 20 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 PACKAGE (0220-9310-92) / 20 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

0220-9310-04 1 BLISTER PACK in 1 PACKAGE (0220-9310-04) / 60 TABLET in 1 BLISTER PACK 0220-9310-29 1 BLISTER PACK in 1 PACKAGE (0220-9310-29) / 120 TABLET in 1 BLISTER PACK 0220-9310-91 1 BLISTER PACK in 1 PACKAGE (0220-9310-91) / 20 TABLET in 1 BLISTER PACK 0220-9310-92 5 BLISTER PACK in 1 PACKAGE (0220-9310-92) / 20 TABLET in 1 BLISTER PACK

Ingredients (4)

datura stramonium (6 [hp_X]/1) hyoscyamus niger (3 [hp_C]/1) nutmeg (4 [hp_C]/1) passiflora incarnata top (3 [hp_X]/1)

Linked Drug Pages (1)

SleepCalm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30dd55c3-2031-ce2f-e063-6294a90a3f1f", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0016962", "M0006342", "M0008672", "M0516536"], "unii": ["G6W4F0V8Z3", "4WRK2153H3", "AEE24M3MQ9", "CLF5YFS11O"], "spl_set_id": ["a1db8417-baea-6914-e053-2a95a90a2fd3"], "pharm_class_cs": ["Allergens [CS]", "Plant Proteins [CS]", "Dietary Proteins [CS]", "Food Additives [CS]", "Seed Storage Proteins [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Laboratoires Boiron"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKAGE (0220-9310-04)  / 60 TABLET in 1 BLISTER PACK", "package_ndc": "0220-9310-04", "marketing_start_date": "20200401"}, {"sample": false, "description": "1 BLISTER PACK in 1 PACKAGE (0220-9310-29)  / 120 TABLET in 1 BLISTER PACK", "package_ndc": "0220-9310-29", "marketing_start_date": "20201211"}, {"sample": false, "description": "1 BLISTER PACK in 1 PACKAGE (0220-9310-91)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "0220-9310-91", "marketing_start_date": "20210712"}, {"sample": false, "description": "5 BLISTER PACK in 1 PACKAGE (0220-9310-92)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "0220-9310-92", "marketing_start_date": "20250321"}], "brand_name": "SleepCalm", "product_id": "0220-9310_30dd55c3-2031-ce2f-e063-6294a90a3f1f", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "0220-9310", "generic_name": "HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM", "labeler_name": "Laboratoires Boiron", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SleepCalm", "active_ingredients": [{"name": "DATURA STRAMONIUM", "strength": "6 [hp_X]/1"}, {"name": "HYOSCYAMUS NIGER", "strength": "3 [hp_C]/1"}, {"name": "NUTMEG", "strength": "4 [hp_C]/1"}, {"name": "PASSIFLORA INCARNATA TOP", "strength": "3 [hp_X]/1"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20200401", "listing_expiration_date": "20261231"}