FDA.reportPublic FDA data

NDC 54973-3206-01 - Sleep

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
54973-3206
Requested NDC
54973-3206-01
Package NDCs from labels
54973-3206-1, 54973-3206-01
Manufacturer
Hyland's Inc.
Effective date
2022-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's SleepHyland's Inc.2022-12-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3206-1Sleep100 in 1 BOTTLE, PLASTICTABLET1004
54973-3206-1Sleep1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3206SLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S INC.]4Current NDC, Legacy NDC, 2 package rows20221217_8ad9775f-367c-45c9-890d-69a3734965f1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H3SLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H3SLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
ACACIAINACTIVE INGREDIENT5C5403N26OSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSLEEP (HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, AND POTASSIUM PHOSPHATE, DIBASIC) TABLET [HYLAND'S]1

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 5 of 30 · 587 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
unii: CI71S98N1Z
Animal Pathogens Nosode Combination 9419ANIMAL PATHOGENS NOSODE COMBINATIONProfessional Complementary Health Formulas43b6ae2d-c089-4b81-bd15-0c66a84bbdbf2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Sepia Combination 9246SEPIA COMBINATIONProfessional Complementary Health Formulasfe79986b-7b2d-4cfd-8386-45de02115ca92026-01-08WarningsExact identifier
unii: 1NM3M2487K
Female Balance Liquescence 3009FEMALE BALANCE LIQUESCENCEProfessional Complementary Health Formulas1ed04735-32ea-4582-94e2-388e9b540cc12026-01-08WarningsExact identifier
unii: 1NM3M2487K
Lachesis Combination 9229LACHESIS COMBINATIONProfessional Complementary Health Formulas7301c44c-2460-43ad-9cb2-dffdc8ee423c2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: 1NM3M2487K
Southeast Regional 1024SOUTHEAST REGIONALProfessional Complementary Health Formulas7a4ff3cf-6897-4cca-b907-556270642e042026-01-08WarningsExact identifier
unii: 5C5403N26O
Trees 2 1017TREES 2Professional Complementary Health Formulas601c8ffe-35c2-4dcc-a503-7d9b9998e2842026-01-08WarningsExact identifier
unii: 5C5403N26O
Distress Drops 2121DISTRESS DROPSProfessional Complementary Health Formulas901dfa0f-343b-4385-8b25-7e41a1a7cd1d2026-01-08WarningsExact identifier
unii: 1NM3M2487K
unii: 4WRK2153H3
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: 4WRK2153H3
Pineal/Pituitary/Hypothalamus Drops 5022PINEAL/PITUITARY/HYPOTHALAMUS DROPSProfessional Complementary Health Formulas97307e9b-5da3-40d3-a619-0722ca3069802026-01-08WarningsExact identifier
unii: 1NM3M2487K
Hysteria Drops 2119HYSTERIA DROPSProfessional Complementary Health Formulas7fe11cce-22f4-47e8-8006-ff5b2b2b23712026-01-08WarningsExact identifier
unii: 1NM3M2487K
Arsenicum Combination 9251ARSENICUM COMBINATIONProfessional Complementary Health Formulasc52598b3-7100-4410-a4cb-b3dcacf445d72026-01-08WarningsExact identifier
unii: 1NM3M2487K
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 1NM3M2487K
Dissociative Disorders Formula 2118DISSOCIATIVE DISORDERS FORMULAProfessional Complementary Health Formulasd512a350-8e3c-4f89-8e12-0dccca61ea862026-01-08WarningsExact identifier
unii: 4WRK2153H3
Epilepsy Drops 2020EPILEPSY DROPSProfessional Complementary Health Formulasb5cc19d2-5200-498c-9742-5967d90479282026-01-08WarningsExact identifier
unii: 4WRK2153H3
Female Endocrine Axis Drops 5005FEMALE ENDOCRINE AXIS DROPSProfessional Complementary Health Formulas76d6ab4c-deeb-4c2c-b072-169888bcac012026-01-08WarningsExact identifier
unii: 1NM3M2487K
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: 1NM3M2487K
Ignatia amara 7122IGNATIA AMARAProfessional Complementary Health Formulasd7cdb581-bd6d-44ab-afba-b7c241c375db2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Neuro Relax Drops 2055NEURO RELAX DROPSProfessional Complementary Health Formulas50cf1c24-4ae9-42e8-a2a3-4d83cc5bfb5a2026-01-08WarningsExact identifier
unii: 1NM3M2487K

Reported adverse events (FAERS/openFDA)#

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