sleepcalm

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

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

Drug Facts

Product Profile

Brand Name sleepcalm
Generic Name hyoscyamus niger, nutmeg, passiflora incarnata flowering top, datura stramonium
Labeler boiron
Dosage Form PELLET
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
Boiron

Identifiers & Regulatory

Product NDC 0220-9311
Product ID 0220-9311_16c77587-39d7-31cf-e063-6294a90a7f22
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2022-04-27

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 02209311
Hyphenated Format 0220-9311

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 flowering 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
  • 2 TUBE in 1 BOX (0220-9311-42) / 80 PELLET in 1 TUBE (0220-9311-41)
source: ndc

Packages (1)

0220-9311-42 2 TUBE in 1 BOX (0220-9311-42) / 80 PELLET in 1 TUBE (0220-9311-41)

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": "16c77587-39d7-31cf-e063-6294a90a7f22", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0016962", "M0006342", "M0008672", "M0516536"], "unii": ["G6W4F0V8Z3", "4WRK2153H3", "AEE24M3MQ9", "CLF5YFS11O"], "spl_set_id": ["dda7a51d-7c2c-67f4-e053-2a95a90a8e72"], "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": ["Boiron"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 BOX (0220-9311-42)  / 80 PELLET in 1 TUBE (0220-9311-41)", "package_ndc": "0220-9311-42", "marketing_start_date": "20220427"}], "brand_name": "SleepCalm", "product_id": "0220-9311_16c77587-39d7-31cf-e063-6294a90a7f22", "dosage_form": "PELLET", "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": "0220-9311", "generic_name": "HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM", "labeler_name": "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": "20220427", "listing_expiration_date": "20261231"}