FDA.reportPublic FDA data

NDC 54973-3324-01 - Baby Nighttime Oral Pain Relief

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
54973-3324
Requested NDC
54973-3324-01
Package NDCs from labels
54973-3324-1, 54973-3324-4, 54973-3324-01
Manufacturer
Hyland' Inc.
Effective date
2026-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Baby Oral Pain Relief NighttimeHyland' Inc.2026-10-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3324-1Baby Nighttime Oral Pain Relief1 g in 1 BOTTLE, PLASTICTABLET113
54973-3324-1Baby Nighttime Oral Pain Relief1 in 1 CARTONTABLET113
54973-3324-4Baby Nighttime Oral Pain Relief6 g in 1 PACKETTABLET613

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3324BABY NIGHTTIME ORAL PAIN RELIEF (ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE) TABLET [HYLAND' INC.]13Current NDC, Legacy NDC, 3 package rows20250321_58ef86b7-5b38-1591-e053-2991aa0aa53e.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 8 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d5058d-861a-9e20-e063-6294a90a164c2026-06-09WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: 91GQH8I5F7
BM Calc PhosCALCAREA PHOSPHORICATotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba8260-0f5a-ff74-e063-6294a90ad30a2026-06-08WarningsExact identifier
unii: 91D9GV0Z28
BM Ferr PhosFERRUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba97b3-db1d-6d8a-e063-6394a90aa8f12026-06-08WarningsExact identifier
unii: 91GQH8I5F7
BM Mag PhosMAGNESIUM PHOSPHATETotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba9cd0-445d-7ca7-e063-6394a90ae5a72026-06-08WarningsExact identifier
unii: HF539G9L3Q
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ThyroplexFUCUS VESICULOSUS, SPONGIA TOSTA, IODIUM, PULSATILLA (VULGARIS), GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), LEVOTHYROXINUM, CALCAREA CARBONICA, FERRUM IODATUM, KALI IODATUM, LYCOPUS VIRGINICUS, PHOSPHORICUM ACIDUMBioActive Nutritional977b06c5-e861-4cc4-ac56-1a960276bb852026-06-08WarningsExact identifier
unii: 2E32821G6I
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 2E32821G6I
Arnica Montana 30X HPUSARNICA MONTANAVITAMEDICA, INC.31c5546e-ee55-4cc1-b601-ce27851e47c92026-06-08WarningsExact identifier
unii: O80TY208ZW
ARNICA MONTANA 30X HPUSARNICA MONTANAVITAMEDICA, INC.40836bb5-a4a8-4fba-82ea-f9aa41cba4e62026-06-08WarningsExact identifier
unii: O80TY208ZW
InjuryARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLADONNA, BELLIS PERENNIS, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, MILLEFOLIUM, RHUS TOX, RUTA GRAVEOLENS, VERATRUM ALBUMBioActive Nutritional, Inc.a1189c23-f8a8-47fd-8a5e-e7d29a6761882026-06-08WarningsExact identifier
unii: O80TY208ZW
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: O80TY208ZW
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 2E32821G6I
Insomnia HPARSENICUM ALBUM, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISBioActive Nutritional, Inc.cd17b39e-6531-407d-8007-8cb92a6e87442026-06-04WarningsExact identifier
unii: 3SW678MX72
LumbagoforceARNICA MONTANA, HYPERICUM PERFORATUM, GNAPHALIUM POLYCEPHALUM, SYMPHYTUM OFFICINALE, COLOCYNTHIS, FORMICA RUFA, RHUS TOXBioActive Nutritional, Inc.6f40e6e6-3e14-42e6-a504-be74e0b86dcf2026-06-04WarningsExact identifier
unii: O80TY208ZW
BM Calc Phos Icing SugarCALCAREA PHOSPHORICATotal Operations Management LLC DBA:Bestmade Natural Products Micro5355390d-9a41-a730-e063-6294a90aa3b62026-06-03WarningsExact identifier
unii: 91D9GV0Z28
BM Ferr Phos Icing SugarFERRUM PHOSPHORICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535597a4-0104-85fe-e063-6294a90a47d02026-06-03WarningsExact identifier
unii: 91GQH8I5F7
BM Mag Phos Icing SugarMAGNESIUM PHOSPHORICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5355f7ce-5221-bceb-e063-6294a90a39532026-06-03WarningsExact identifier
unii: HF539G9L3Q
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Camilia BedtimeMATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, PHYTOLACCA AMERICANA ROOT, RHEUM OFFICINALE ROOTBoiron200c2af6-b457-b8bc-e063-6294a90a38002026-06-02Exact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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