NDC 54973-3315-01 - Baby 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
54973-3315
Requested NDC
54973-3315-01
Package NDCs from labels
54973-3315-1, 54973-3315-3, 54973-3315-7, 54973-3315-01
Manufacturer
Hyland' Inc. | Hyland's 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 DaytimeHyland' Inc. | Hyland's Inc.2026-10-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3315-1Baby Oral Pain Relief1 in 1 CARTONTABLET115
54973-3315-1Baby Oral Pain Relief125 g in 1 BOTTLE, PLASTICTABLET12515
54973-3315-3Baby Oral Pain Relief6 g in 1 PACKETTABLET615
54973-3315-7Baby Oral Pain Relief1 in 1 CARTONTABLET115
54973-3315-7Baby Oral Pain Relief80 g in 1 BOTTLE, PLASTICTABLET8015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3315BABY ORAL PAIN RELIEF (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, ARABICA COFFEE BEAN, ARNICA MONTANA, FERRUM PHOSPHORICUM AND MATRICARIA CHAMOMILLA) TABLET [HYLAND' INC.]15Current NDC, Legacy NDC, 5 package rows20250209_5904f126-e8f0-a892-e053-2991aa0aef0f.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 80 · 1,591 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph DrainageBAPTISIA TINCTORIA, CITRUS LIMONUM, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, TEUCRIUM SCORODONIA, THUJA OCCIDENTALIS, CAPSICUM ANNUUM, CUPRUM SULPHURICUM, KALI MURIATICUM, MANGANUM MURIATICUM, ARSENICUM IODATUM, CARPINUS BETULUS, FLOS, CENTAURIUM UMBELLATUM, FLOS, GALIUM APARINE, LARIX DECIDUA, FLOS, ROSA CANINA, SCROPHULARIA NODOSA, ZINCUM GLUCONICUM, ARANEA DIADEMA, CALCAREA CARBONICA, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, LACHESIS MUTUSCarnivora Research International57be5edd-a45b-40e4-b095-fafbfd3dc7032026-04-20WarningsExact identifier
unii: 2E32821G6I
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 2E32821G6I
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: O80TY208ZW
Pneumo HPAMMONIUM MURIATICUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, LOBELIA INFLATA, NATRUM SULPHURICUM, SPONGIA TOSTA, PHOSPHORUS,BioActive Nutritional, Inc.532dd216-746c-4a56-98b4-cf90e2e509ac2026-04-17WarningsExact identifier
unii: 2E32821G6I
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: 91D9GV0Z28
H-Calm FormulaACONITUM NAPELLUS, ALFALFA, AVENA SATIVA, CHAMOMILLA, CISTUS CANADENSIS, CLEMATIS VITALBA, FLOS, IMPATIENS GLANDULIFERA, FLOS, KALI PHOSPHORICUM, LILIUM TIGRINUM, ORNITHOGALUM UMBELLATUM, FLOS, PASSIFLORA INCARNATA, PHOSPHORUS, PRUNUS CERASIFERA, FLOS, PULSATILLA, VALERIANA OFFICINALISHealing Natural Oils LLC4ee311e9-626a-a73c-e063-6294a90a773b2026-04-07WarningsExact identifier
unii: G0R4UBI2ZZ
Chestal Cold and Cough HoneySOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDBoiron4ecd2dcf-7664-00b9-e063-6394a90a96862026-04-06WarningsExact identifier
unii: 91GQH8I5F7
Chestal Kids Cold and Cough HoneySOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDBoiron4e8ff89e-f9e8-8618-e063-6294a90a6b3e2026-04-03WarningsExact identifier
unii: 91GQH8I5F7
CirculationNIACIN, NICOTINAMIDUM, ARNICA MONTANA, CAMPHORA, NUX VOMICA, STROPHANTHUS HISPIDUS, VERATRUM ALBUM, ADRENALINUM, AESCULUS HIPPOCASTANUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HELODERMA (HORRIDUS), RHUS TOX, TABACUMNutritional Specialties, Inc.220bbbf3-d54d-4222-b540-e197927ab8bc2026-04-01WarningsExact identifier
unii: O80TY208ZW
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: 2E32821G6I
Arnica Montana 200C HPUSARNICA MONTANAVITAMEDICA, INC.3d6cb757-e0e7-656e-e063-6394a90a3d9e2026-03-31WarningsExact identifier
unii: O80TY208ZW
Arnica Montana 30C HPUSARNICA MONTANAVITAMEDICA, INC.3d6bfff9-16a2-8ff8-e063-6394a90a2bda2026-03-31WarningsExact identifier
unii: O80TY208ZW
IntestaforceALTHAEA OFFICINALIS, CAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILISBioActive Nutritional, Inc.e4bdfc07-f252-45bf-bb06-f8403ce375b12026-03-31WarningsExact identifier
unii: 91GQH8I5F7
Dizzy FormulaARNICA MONTANA, HYDROCOTYLE ASIATICA, AMBRA GRISEA, ARGENTUM NITRICUM, COCCULUS INDICUS, CONIUM MACULATUM, LAC CANINUM, THERIDIONNutritional Specialties, Inc.aaccfd13-6559-4976-90d1-aa3b4a4a79db2026-03-31WarningsExact identifier
unii: O80TY208ZW
CirculatoneFAGOPYRUM ESCULENTUM, MAGNESIA MURIATICA, CITRUS BIOFLAVONOIDS, HEART (SUIS), THYROIDINUM (SUIS), ARSENICUM IODATUM, AURUM MURIATICUM, BARYTA MURIATICA, CALCAREA IODATA, CHOLESTERINUM, CONIUM MACULATUM, KALI IODATUM, PLUMBUM METALLICUM, ARNICA MONTANA, PHOSPHORUSBioActive Nutritional, Inc.465fb3c6-88e6-4099-a26a-33991ec5a1062026-03-31WarningsExact identifier
unii: O80TY208ZW
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: G0R4UBI2ZZ
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 2E32821G6I
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: 91D9GV0Z28
Lymph Tonic IECHINACEA (ANGUSTIFOLIA), KALI IODATUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, HYPOPHYSIS SUIS, APIS MELLIFICA, ARANEA DIADEMA, BELLADONNA, CALCAREA CARBONICA, CLEMATIS ERECTA, CONIUM MACULATUM, GALIUM APARINE, GRAPHITES, LACHESIS MUTUS, MERCURIUS PRAECIPITATUS RUBER, MYRISTICA SEBIFERA, PHOSPHORUS, RHUS TOX, SCROPHULARIA NODOSA, SULPHUR, THYROIDINUM (SUIS), VESPA CRABROBioActive Nutritional, Inc.9b9a639c-0a91-48b5-b1ff-6b82c6a568ef2026-03-27WarningsExact identifier
unii: 2E32821G6I
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 2E32821G6I

Reported adverse events (FAERS/openFDA)#

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