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 14 of 47 · 931 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.897a3348-4d9d-4f74-a330-d6492baa4d032025-11-20WarningsExact identifier
unii: 639KR60Q1Q
unii: CLF5YFS11O
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
unii: 639KR60Q1Q
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: G0R4UBI2ZZ
ANXIETY II HPACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, HUMAN BREAST TUMOR CELL, CAUSTICUM, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, MERCURY, SODIUM CHLORIDE, NITRIC ACID, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAFNatural Creations, Inc.02fa45a5-08e1-41ad-acd4-0f85db07e89e2025-11-13WarningsExact identifier
unii: 639KR60Q1Q
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: G0R4UBI2ZZ
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: G0R4UBI2ZZ
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a26648-fd6e-9696-e053-2991aa0a5bf22025-10-27Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron7b4d5a40-7a53-11e6-a4bf-424c583030312025-10-27Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a28641-dd2f-b8a7-e053-2a91aa0a6d242025-10-27Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2d779-ed87-f4ab-e053-2991aa0aa4872025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2d01d-5d86-5133-e053-2a91aa0add452025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a29037-8c13-25e2-e053-2a91aa0a08452025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2aa5a-29cc-6ef2-e053-2a91aa0a019c2025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a29d28-b47b-e877-e053-2991aa0ac0492025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a2ce33-bfb9-b8a9-e053-2a91aa0ae3ca2025-10-24Exact identifier
unii: 639KR60Q1Q
Gelsemium sempervirensGELSEMIUM SEMPERVIRENS ROOTBoiron85a33d3e-7194-a722-e053-2a91aa0a760f2025-10-24Exact identifier
unii: 639KR60Q1Q
Sambucus Cold Flu Relief ElderberryPELARGONIUM SIDOIDES ROOT, ACONITUM NAPELLUS, EUCALYPTUS GLOBULUS LEAF, SAMBUCUS NIGRA FLOWERING TOP, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECACSchwabe North America, Inc.aaa28ba9-6abd-46da-8ffa-83178505aeee2025-10-22WarningsExact identifier
unii: 639KR60Q1Q
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
unii: J2B2A4N98G
Cedar X FormulaOLIBANUM, THUJA OCCIDENTALIS, GELSEMIUM SEMPERVIRENS, ALLIUM CEPA, ANTIMONIUM TARTARICUM, HEPAR SULPHURIS CALCAREUM, JUNIPERUS COMMUNIS.Integrative Healing Institute, LLC8ab87e13-99ad-4b25-a0c3-e46a868cc6842025-10-17WarningsExact identifier
unii: 639KR60Q1Q
Mold Relief FormulaKALI MURIATICUM, GELSEMIUM, KALI BICHROMICUM, SABADILLA, HISTAMINUM, MOLD MIX.Integrative Healing Institute, LLC067ee707-7219-4370-9cdd-08888f45b5e52025-10-17WarningsExact identifier
unii: 639KR60Q1Q

Reported adverse events (FAERS/openFDA)#

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