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 6 of 30 · 587 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Formula III Drops 2091PAIN FORMULA III DROPSProfessional Complementary Health Formulas3d95fb9c-c3ce-4b66-93d0-04bddae799222026-01-08WarningsExact identifier
unii: 1NM3M2487K
Argentum Combination 9207ARGENTUM COMBINATIONProfessional Complementary Health Formulasd1870494-1654-42d1-a867-6fd2fe0bfdac2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Attention Deficit Severe Drops 2147ATTENTION DEFICIT SEVERE DROPSProfessional Complementary Health Formulascd45062c-f3b1-439f-a559-3582d5c621732026-01-08WarningsExact identifier
unii: 4WRK2153H3
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: 4WRK2153H3
Anti-Stress Drops 2009ANTI-STRESS DROPSProfessional Complementary Health Formulas3557c501-66d9-49eb-8996-028ed8274e292026-01-08WarningsExact identifier
unii: 1NM3M2487K
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: 4WRK2153H3
Magnesium Combination 9232MAGNESIUM COMBINATIONProfessional Complementary Health Formulas4d99b3ec-724f-4385-ae5e-83389bb0c8fe2026-01-08WarningsExact identifier
unii: 4WRK2153H3
Terebinthina Combination 9248TEREBINTHINA COMBINATIONProfessional Complementary Health Formulas1363fff1-3b37-47d8-a17b-8bf8e72f66162026-01-08WarningsExact identifier
unii: 1NM3M2487K
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 1NM3M2487K
RET Kidney 7005RET KIDNEYProfessional Complementary Health Formulas017f4c37-3eec-4078-9ce6-aca52fd4974d2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Stress Tonic 2998STRESS TONICProfessional Complementary Health Formulas1f53201a-427a-4342-b510-890c33b9c4c62026-01-08WarningsExact identifier
unii: 1NM3M2487K
Baryta Combination 9209BARYTA COMBINATIONProfessional Complementary Health Formulascca7da01-b28b-46c3-b025-d0bd12074aa12026-01-08WarningsExact identifier
unii: 1NM3M2487K
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Selenium Combination 9245SELENIUM COMBINATIONProfessional Complementary Health Formulas1c2cc0ad-f859-470b-be4b-f98e010a2e5c2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Pollinosis Combination 9261POLLINOSIS COMBINATIONProfessional Complementary Health Formulas2a4336d2-dcaa-4a15-95e5-b76c5646825a2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 1NM3M2487K
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 1NM3M2487K
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: 1NM3M2487K
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 1NM3M2487K
unii: 4WRK2153H3
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: 4WRK2153H3

Reported adverse events (FAERS/openFDA)#

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