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 27 of 46 · 908 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChamomillaMATRICARIA CHAMOMILLABoiron851978dd-d0dd-208c-e053-2a91aa0a30c52024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron8519e65a-803a-2986-e053-2a91aa0aadfd2024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62b1-30ad-e053-2991aa0a19bd2024-07-22Exact identifier
unii: G0R4UBI2ZZ
ChamomillaMATRICARIA CHAMOMILLABoiron851a1844-b599-62c5-e053-2a91aa0a81742024-07-22Exact identifier
unii: G0R4UBI2ZZ
RelaxatonePASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDAEnergique, Inc.98fd169f-84b7-415e-a7e8-bbb7d7f81ac42024-07-12WarningsExact identifier
unii: CLF5YFS11O
Cold plus FluANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTIMONIUM TARTARICUM, APIS MELLIFICA, BAPTISIA TINCTORIA, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LUNG SUIS, SAMBUCUS NIGRA, SERUM ANGUILLAE, STICTA PULMONARIALiddell Laboratories, Inc.46193f5d-e9d7-4b34-b69e-d2a490788da02024-07-01WarningsExact identifier
unii: 639KR60Q1Q
PMSAPIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.575b4736-5bae-4f15-b55b-3e1fbbb613ff2024-07-01WarningsExact identifier
unii: G0R4UBI2ZZ
Back Pain and SciaticaACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOXLiddell Laboratories, Inc.2ae11146-b869-4a53-afa3-805de12921f92024-07-01WarningsExact identifier
unii: 639KR60Q1Q
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: OSD78555ZM
STRAMONIUMSTRAMONIUMRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a48fc33-1f00-70a9-e063-6394a90a51412024-06-07WarningsExact identifier
unii: G6W4F0V8Z3
PASSIFLORA INPASSIFLORA INRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a4948b4-cc89-2ccd-e063-6394a90aa31c2024-06-07WarningsExact identifier
unii: CLF5YFS11O
KALI BROMKALI BROMRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a34f20a-a323-8be8-e063-6394a90af80b2024-06-06WarningsExact identifier
unii: OSD78555ZM
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUMNutritional Specialties, Inc.2f4acf3d-09d7-4dcc-b23c-793b0e2d53b12024-06-05WarningsExact identifier
unii: 4WRK2153H3
CHAMOMILLACHAMOMILLARxhomeo Private Limited d.b.a. Rxhomeo, Inc1a0d7bbf-6779-7b67-e063-6394a90a1e5c2024-06-04WarningsExact identifier
unii: G0R4UBI2ZZ
GELSEMIUM SGELSEMIUM SRxhomeo Private Limited d.b.a. Rxhomeo, Inc19ce6fa0-9413-68c1-e063-6294a90aa58c2024-06-01WarningsExact identifier
unii: 639KR60Q1Q
HYOSCYAMUS NIGHYOSCYAMUS NIGRxhomeo Private Limited d.b.a. Rxhomeo, Inc19cf0f81-a549-d0b5-e063-6294a90a7de92024-06-01WarningsExact identifier
unii: 4WRK2153H3
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUMNutritional Specialties, Inc.2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc2024-05-31WarningsExact identifier
unii: 4WRK2153H3
Sambucol Cold and Flu ReliefBRYONIA, GELSEMIUM SEMPERVIRENS, SABUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMPharmaCare US, Inc.7dace656-ee97-4931-869f-8c8022757abb2024-05-24WarningsExact identifier
unii: 639KR60Q1Q
Multiple MiasmACONITUM NAPELLUS, ALOE, ARSENICUM ALBUM, AURUM METALLICUM, BRYONIA (ALBA), CACTUS GRANDIFLORUS, CALCAREA SULPHURICA, CINCHONA OFFICINALIS, HURA BRASILIENSIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, PHOSPHORUS, SARCOLACTICUM ACIDUM, SILICEA, STRAMONIUM, SULPHUR, TARENTULA HISPANA, TEUCRIUM MARUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.92c97bf6-8dd9-43a9-b686-75420b0291972024-05-21WarningsExact identifier
unii: G6W4F0V8Z3
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
unii: 639KR60Q1Q
unii: 4WRK2153H3
unii: G6W4F0V8Z3
unii: J2B2A4N98G
unii: G0R4UBI2ZZ

Reported adverse events (FAERS/openFDA)#

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