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 36 of 46 · 908 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Passiflora incarnataPASSIFLORA INCARNATA FLOWERING TOPBoiron865c4aad-7d88-3938-e053-2a91aa0afab62023-03-03Exact identifier
unii: CLF5YFS11O
INFL CombinationEUCALYPTUS GLOBULUS, IPECACUANHA, ACONITUM NAPELLUS, ADENOVIREN NOSODE, INFLUENZINUM 2021-2022, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KREOSOTUM, VERATRUM VIRIDEDeseret Biologicals, Inc.e54d3fc8-e9a7-424c-a0d8-3325e00db5ee2023-02-27WarningsExact identifier
unii: 639KR60Q1Q
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
Hyoscyamus nigerHYOSCYAMUS NIGERBoiron35db22f0-2a55-11e7-82fd-424c583030312023-02-20Exact identifier
unii: 4WRK2153H3
StramoniumDATURA STRAMONIUMBoiron86a6d271-dd59-11af-e053-2a91aa0a884a2023-02-20Exact identifier
unii: G6W4F0V8Z3
Hyoscyamus nigerHYOSCYAMUS NIGERBoiron85c966d1-feca-78c8-e053-2991aa0aa21b2023-02-20Exact identifier
unii: 4WRK2153H3
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
Pain and Fatigue ReliefACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, CONIINUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI BICHROMICUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, URICUM ACIDUMThe Magni Company7c689153-2002-421d-b573-76b0052550e02023-01-26WarningsExact identifier
unii: 639KR60Q1Q
StramoniumDATURA STRAMONIUMBoiron910e68b0-7c74-11e6-89dd-424c583030312023-01-23Exact identifier
unii: G6W4F0V8Z3
Kali bromatumPOTASSIUM BROMIDEBoiron8517ac7c-8a4b-def4-e053-2991aa0a2fa02023-01-18Exact identifier
unii: OSD78555ZM
StramoniumDATURA STRAMONIUMBoiron86a77a11-d888-0e65-e053-2a91aa0aa8cb2023-01-13Exact identifier
unii: G6W4F0V8Z3
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 639KR60Q1Q
AllermilkTARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), MENADIONE, OOPHORINUM (SUIS), PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, QUERCETIN, RUTIN, SACCHARUM LACTIS, TYRAMINE, XANTHINE, COUMARINUM, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), VANILLYLAMINE, APIOLUMDeseret Biologicals, Inc.c13cbfb9-1c1f-43b5-b218-e58c3c521f932023-01-12WarningsExact identifier
unii: J2B2A4N98G
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.f267fff4-f331-49b8-bd48-7d383da522462023-01-11WarningsExact identifier
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Calm Anxiety and StressCLEMATIS VITALBA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, ANGELICA SINENSIS, ARGENTUM NITRICUM, CACAO, LITHIUM CARBONICUM, PRUNUS CERASIFERA, FLOS, VALERIANA OFFICINALIS, PIPER METHYSTICUM, GLANDULA SUPRARENALIS SUIS, ACONITUM NAPELLUS, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, IGNATIA AMARA, GELSEMIUM SEMPERVIRENSPro Weight Loss Inc.f5fb248f-e078-4dba-9bee-be0e803b6a132023-01-10WarningsExact identifier
unii: 639KR60Q1Q
unii: CLF5YFS11O
Weight ManagementASCLEPIAS 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 (7-KETO), ADENOSINUM TRIPHOSPHORICUM DINATRUM, INSULINUM (SUIS), SARCOLACTICUM ACIDUM, PROTEUS (VULGARIS)Pro Weight Loss Inc.399ce7ef-dd53-438c-9d58-c70aba8e3cb22023-01-10WarningsExact identifier
unii: 639KR60Q1Q
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Passiflora incarnataPASSIFLORA INCARNATA FLOWERING TOPBoiron865c2765-507e-d029-e053-2a91aa0a098e2023-01-06Exact identifier
unii: CLF5YFS11O
Hyoscyamus nigerHYOSCYAMUS NIGERBoiron85c9345a-6bf1-18fa-e053-2991aa0a66cd2023-01-06Exact identifier
unii: 4WRK2153H3

Reported adverse events (FAERS/openFDA)#

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