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 13 of 47 · 931 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERM HPAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.15dc5391-0e6e-45d9-8ac7-142333a907162025-12-12WarningsExact identifier
unii: G0R4UBI2ZZ
FLU HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOTNatural Creations, Inc.3d6c203a-6f30-4417-84d3-3cdab22098e32025-12-10WarningsExact identifier
unii: 639KR60Q1Q
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: G6W4F0V8Z3
DIARRHEA CPAETHUSA CYNAPIUM, ARSENIC TRIOXIDE, OYSTER SHELL CALICUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLOBILIS, PHOSPHORUS, PODOPHYLLUM, ANEMONE PULSATILLA, DELPHINIUM STRAPHISAGRIA SEED, SULFURNatural Creations, Inc.06f51c41-1e76-4201-937a-cbaaf6a477af2025-12-10WarningsExact identifier
unii: G0R4UBI2ZZ
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: G6W4F0V8Z3
Sambucus Flu ReliefACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOPSchwabe North America, Inc.ca7d57b0-ffae-415f-a959-b0c88ae7dd402025-12-08WarningsExact identifier
unii: 639KR60Q1Q
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 639KR60Q1Q
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffb50a-7bfe-428b-e063-6394a90a9dcf2025-12-02WarningsExact identifier
unii: 639KR60Q1Q
Headache-MigraineELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.45002cee-75e1-1d1a-e063-6294a90a6e0d2025-12-02WarningsExact identifier
unii: 639KR60Q1Q
Digestive CareBISMUTHUM METALLICUM, ANTIMON.CRUD., ARG. NIT., ARSENICUM ALB., BAPTISIA, BRYONIA, CHAMOMILLA, CINCHONA, IRIS VERSICOLOR, KALI BIC., LACHESIS, LYCOPODIUM, MAG. CARB., NUX VOM., PHOSPHORUS, PODOPH. PELT., PULSATILLA, RAPHANUS, RHUS TOXICODENDRON, TABACUM, VERBASCUM, ZINGIBER, ECHINACEA, JUGLANS REGIA.Newton Laboratories, Inc.44e7e28b-88e5-784b-e063-6294a90a60022025-12-01WarningsExact identifier
unii: G0R4UBI2ZZ
HeadacheELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..Newton Laboratories, Inc.44ffafd7-8b43-5a24-e063-6294a90a80a32025-12-01WarningsExact identifier
unii: 639KR60Q1Q
Triple Flu DefenseACONITUM NAPELLUS, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTIMONIUM CRUDUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, INFLUENZINUM, IPECACUANHA, KALI BICHROMICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRANenningers Naturals, LLC43bbed35-e351-409a-b6b6-7da1959634bf2025-11-25WarningsExact identifier
unii: 639KR60Q1Q
Genexa Kids Calm KeeperACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISGenexa Inc.ba5de524-dac6-8b54-e053-2995a90ac6ef2025-11-25WarningsExact identifier
unii: 639KR60Q1Q
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: 639KR60Q1Q
Pollen DistressALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENSLiddell Laboratories, Inc.a05f7d34-9f5c-42a4-a9f5-8e62e1e860202025-11-20WarningsExact identifier
unii: 639KR60Q1Q
ECZEMANICCOLUM SULPHURICUM, KALI BROMATUM, KALI MURIATICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, KALI SULPHURICUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC624d8671-43ce-46a8-87d3-d491fd9ba9132025-11-20WarningsExact identifier
unii: OSD78555ZM
ACNENICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC6cdd54fa-6997-48da-8209-86e530f83c612025-11-20WarningsExact identifier
unii: OSD78555ZM
Psorizide ForteNICKEL SULFATE, POTASSIUM BROMIDE, AND FUMARIC ACIDPLYMOUTH HEALTHCARE PRODUCTS LLC7896794a-60bd-4dfa-abfe-aa29aaa6f74d2025-11-20Warnings, Adverse reactionsExact identifier
unii: OSD78555ZM
PSORIASISNICCOLUM SULPHURICUM, NATRUM BROMATUM, ZINCUM BROMATUM, KALI BROMATUM, KALI SULPHURICUM.PLYMOUTH HEALTHCARE PRODUCTS LLC7ad9e8ac-c8a3-4cab-8ab2-15feaf4bd3dc2025-11-20WarningsExact identifier
unii: OSD78555ZM
EczemolPOTASSIUM BROMIDE, NICKEL SULFATE, AND SULFURPLYMOUTH HEALTHCARE PRODUCTS LLC981e9f3d-b608-4a5e-92f8-895b22da12f42025-11-20Warnings, Adverse reactionsExact identifier
unii: OSD78555ZM

Reported adverse events (FAERS/openFDA)#

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