FDA.reportPublic FDA data

NDC 0220-9308-41 - SleepCalm

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0220-9308
Requested NDC
0220-9308-41
Package NDCs from labels
0220-9308-41, 0220-9308-42
Manufacturer
Boiron | Boiron, Inc.
Effective date
2025-03-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SleepCalm Kids PelletBoiron | Boiron, Inc.2025-03-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9308-41SleepCalm80 in 1 TUBEPELLET803
0220-9308-42SleepCalm2 in 1 BOXPELLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9308SLEEPCALM (MATRICARIA CHAMOMILLA WHOLE, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM) PELLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20250312_de0b458d-5f0a-78f4-e053-2995a90afe4b.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 35 of 46 · 908 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fecece1f-22bc-21dc-e053-6294a90ad0c32023-06-23WarningsExact identifier
unii: 639KR60Q1Q
unii: G6W4F0V8Z3
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fed03a1c-0ea8-1f8e-e053-6394a90a04c02023-06-23WarningsExact identifier
unii: 639KR60Q1Q
unii: G6W4F0V8Z3
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
unii: 639KR60Q1Q
unii: G6W4F0V8Z3
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: G0R4UBI2ZZ
Anxiety II HPACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARCINOSIN, CAUSTICUM, GELSEMIUM SEMPERVIRENS, LACHESIS MUTUS, MERCURIUS VIVUS, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOXBioActive Nutritional, Inc.c4f51f32-beb3-410a-9ff3-f5c27bbb37c32023-06-06WarningsExact identifier
unii: 639KR60Q1Q
HA2CG EvolutionASCLEPIAS VINCETOXICUM, ECHINACEA (ANGUSTIFOLIA), HYPOTHALAMUS (SUIS), CEREBRUM SUIS, HEPAR SUIS, KIDNEY (SUIS), METHYLCOBALAMIN, PANCREAS SUIS, STOMACH (SUIS), AACG-A, AACG-B, CALCAREA CARBONICA, GELSEMIUM SEMPERVIRENS, GRAPHITES, NUX VOMICA, PHYTOLACCA DECANDRA, GAMBOGIA, 7-OXO-DEHYDROEPIANDROSTERONE 3-ACETATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, INSULINUM (SUIS), SARCOLACTICUM ACIDUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.83f20d41-de0e-45d3-91d5-6a85315e36092023-05-31WarningsExact identifier
unii: 639KR60Q1Q
Cold ArmorALLIUM CEPA, HYDRASTIS CANADENSIS, PULSATILLA (PRATENSIS), DULCAMARA, NUX VOMICA, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUMRatis, LLC46af3f19-055e-4025-a14e-1d6c25880f4d2023-05-26WarningsExact identifier
unii: 639KR60Q1Q
PeacefuliAVENA SATIVA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, KALI PHOSPHORICUM, ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, IGNATIA AMARARatis, LLCeb3bc662-3d3d-4e4d-8561-330ad0eb08f22023-05-25WarningsExact identifier
unii: CLF5YFS11O
BHI BackAMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, AND TOXICODENDRON PUBESCENS LEAFMediNatura Incaa622a5b-16de-4098-9c3f-d7569f7d2c2f2023-05-23WarningsExact identifier
unii: 639KR60Q1Q
unii: G0R4UBI2ZZ
Hyoscyamus NigerHYOSCYAMUS NIGERTrue Botanica, LLC6195633c-839c-228b-e053-2a91aa0aecdf2023-05-01WarningsExact identifier
unii: 4WRK2153H3
Hyoscyamus NigerHYOSCYMUS NIGERTrue Botanica, LLC61953eb2-1f6c-06c7-e053-2a91aa0a0ae42023-05-01WarningsExact identifier
unii: 4WRK2153H3
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: G0R4UBI2ZZ
ChamomillaCHAMOMILLANewton Laboratories, Inc.f912a32e-9bc9-c195-e053-6294a90a3e202023-04-11WarningsExact identifier
unii: G0R4UBI2ZZ
Hyoscyamus nigerHYOSCYAMUS NIGERBoiron85c8f929-d8d9-2a24-e053-2a91aa0ae3d12023-03-27Exact identifier
unii: 4WRK2153H3
T-ReliefARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc2bd442ca-0bbe-0bc3-e054-00144ff8d46c2023-03-21WarningsExact identifier
unii: G0R4UBI2ZZ
TraumedARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc8cd4745f-2f4b-4cdf-868b-c5a089a165992023-03-21WarningsExact identifier
unii: G0R4UBI2ZZ
TraumexARNICA MONTANA WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,BAPTISIA TINCTORIA ROOT, BELLIS PERENNIS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE,ACONITUM NAPELLUS WHOLE,MATRICARIA CHAMOMILLA WHOLE,ACHILLEA MILLEFOLIUM WHOLE,ATROPA BELLADONNA,HYPERICUM PERFORATUM WHOLE,RUTA GRAVEOLENS FLOWERING TOP AND COMFREY ROOTMediNatura Inc335c8bec-f0c3-4b95-a6a6-5fda262be0e62023-03-20WarningsExact identifier
unii: G0R4UBI2ZZ
Hyoscyamus nigerHYOSCYAMUS NIGERBoiron85c98f90-64c9-11fd-e053-2a91aa0a234f2023-03-16Exact identifier
unii: 4WRK2153H3
TraumeelACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM AND COMFREY ROOTBiologische Heilmittel Heel9ff5c743-0e8f-4416-9964-c92b3abb54dd2023-03-06WarningsExact identifier
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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