FDA.reportPublic FDA data

NDC 54973-4010-01 - Fever Reducer

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
54973-4010
Requested NDC
54973-4010-01
Package NDCs from labels
54973-4010-1, 54973-4010-01
Manufacturer
Hyland’s Inc. | Hyland's Inc.
Effective date
2022-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Fever Reducer TabletsHyland’s Inc. | Hyland's Inc.2022-12-12HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4010-1Fever Reducer100 in 1 BOTTLE, PLASTICTABLET1002
54973-4010-1Fever Reducer1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4010FEVER REDUCER (ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT) TABLET [HYLAND’S INC.]2Current NDC, Legacy NDC, 2 package rows20221213_a3d3b0fb-9fca-52ba-e053-2995a90aa3e9.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 19 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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: WQZ3G9PF0H
unii: T7J046YI2B
unii: U0NQ8555JD
Apis Belladonna MercuriusAPIS BELLADONNA MERCURIUSUriel Pharmacy Inc.85c71f6f-3792-4679-aeae-18eaee7db31c2025-11-06WarningsExact identifier
unii: WQZ3G9PF0H
Cough and Mucus Grape FlavorANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,FERROSOFERRIC PHOSPHATE,CALCIUM SULFIDE,IPECAC,PHOSPHORUS,ANEMONE PULSATILLA,RUMEX CRISPUS ROOTHyland'sd0eb15c6-bf12-19b7-e053-2a95a90abbe02025-10-29WarningsExact identifier
unii: T7J046YI2B
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
Belladonna 6XBELLADONNA 6XTrue Botanica, LLC3c1ca101-4859-b62e-e063-6294a90a2fd32025-10-23WarningsExact identifier
unii: WQZ3G9PF0H
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
unii: T7J046YI2B
unii: U0NQ8555JD
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
Seasonal Allergy FormulaHYDRASTIS CANADENSIS, KALI MURIATICUM, GELSEMIUM SEMPERVIRENS, KALI BICHROMICUM, SABADILLA, HISTAMINUM, HOUSE DUST, GRASS MIX, TREES MIX, WEEDS MIXIntegrative Healing Institute, LLC1d4deee9-5452-421b-a107-ab150d1f62142025-10-17WarningsExact identifier
unii: 639KR60Q1Q
Larynx LevisticumLARYNX LEVISTICUMUriel Pharmacy Inc.8db7f52e-648f-4208-8784-ef2a662fe7902025-10-10WarningsExact identifier
unii: T7J046YI2B
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: WQZ3G9PF0H

Reported adverse events (FAERS/openFDA)#

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