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 9 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM CALC PHOS POTENCYCALC PHOSBM Private Limited5322934b-666b-4cef-e063-6394a90a33622026-05-31WarningsExact identifier
unii: 91D9GV0Z28
BM FERR PHOS POTENCYFERR PHOSBM Private Limited53236607-b905-33f7-e063-6394a90a99652026-05-31WarningsExact identifier
unii: 91GQH8I5F7
BM MAG PHOS POTENCYMAG PHOSBM Private Limited5323b433-51d7-db70-e063-6394a90a03bc2026-05-31WarningsExact identifier
unii: HF539G9L3Q
Genexa Kids Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.ae095073-27d1-0aa5-e053-2a95a90a86d42026-05-28WarningsExact identifier
unii: G0R4UBI2ZZ
VARICOSE VEIN MASSAGEARNICA MONTANA WHOLEGuangzhou Shengli Shidai Cosmetics Co., Ltd.52635ff0-361c-36b8-e063-6294a90acbbe2026-05-22WarningsExact identifier
unii: O80TY208ZW
TraumeelATROPA BELLADONNA,ECHINACEA, UNSPECIFIED,ARNICA MONTANA ROOT,ACONITUM NAPELLUS,BELLIS PERENNIS,CALENDULA OFFICINALIS FLOWERING TOP,CALCIUM SULFIDE,HYPERICUM PERFORATUM,COMFREY ROOT,MATRICARIA RECUTITA,HAMAMELIS VIRGINIANA LEAF,ECHINACEA PURPUREA,MERCURIUS SOLUBILIS,ACHILLEA MILLEFOLIUMMediNatura Inc39630b57-28b1-486b-a4ff-4af65324454f2026-05-21WarningsExact identifier
unii: G0R4UBI2ZZ
Bone Pain ReliefCOMFREY ROOT, TRIBASIC CALCIUM PHOSPHATEBoiron52419c5d-bf46-67ca-e063-6294a90a8fe02026-05-20WarningsExact identifier
unii: 91D9GV0Z28
ARNICAREARNICA MONTANALaboratoires Boiron542b41dd-f285-4e48-a67b-8e69523b143a2026-05-20WarningsExact identifier
unii: O80TY208ZW
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
unii: 2E32821G6I
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: O80TY208ZW
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
BM BM36CALC CARB, CALC FLUOR, CISTUS CAN, FRAXINUS, FUCUS VES, OOPHOR, SECALE CORN, THUJA OCCBM Private Limited51514efa-2455-22f3-e063-6394a90a52122026-05-10WarningsExact identifier
unii: 2E32821G6I
BM BM36CALC CARB, CALC FLUOR, CISTUS CAN, FRAXINUS, FUCUS VES, OOPHOR, SECALE CORN, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro5151d623-79a7-d50f-e063-6394a90a451f2026-05-10WarningsExact identifier
unii: 2E32821G6I
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 3SW678MX72
unii: G0R4UBI2ZZ
Radiation PlusFUCUS VESICULOSUS, THYROIDINUM (SUIS), CADMIUM SULPHURATUM, COLCHICUM AUTUMNALE, DNA, IODIUM, PLUMBUM METALLICUM, RADIUM BROMATUM, STRONTIUM CARBONICUM, VISCUM ALBUM, X-RAY, ARNICA MONTANADeseret Biologicals, Inc.8a9fa469-62ef-4538-8ecf-6caa176102642026-05-07WarningsExact identifier
unii: O80TY208ZW
GastrotoneCAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.1ba810f2-ee90-400c-81d7-d066c5eebe592026-05-07WarningsExact identifier
unii: HF539G9L3Q
Lymph Tonic IIIECHINACEA (ANGUSTIFOLIA), BOLDO, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ARNICA MONTANA, CALCAREA IODATA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, NAJA TRIPUDIANS, CALCAREA PHOSPHORICA, NATRUM SULPHURICUM, PYROGENIUM, SULPHUR, CARCINOSIN, INFLUENZINUMBioActive Nutritional, Inc.c39a5867-6865-43ac-b36f-51cbfcbc415f2026-05-06WarningsExact identifier
unii: O80TY208ZW
unii: 91D9GV0Z28
CeleragesicACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA (ALBA), CALENDULA OFFICINALIS, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), ECHINACEA PURPUREA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MILLEFOLIUM, NADIDUM, PANTOTHENIC ACID, RHUS TOX, SARCOLACTICUM ACIDUM, SYMPHYTUM OFFICINALEDeseret Biologicals, Inc.2c328b15-7f00-479c-908b-88c1e5a523982026-05-06WarningsExact identifier
unii: O80TY208ZW
unii: G0R4UBI2ZZ
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, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
Trauma plus GelCALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUMEnergique, Inc.53f4232b-23d4-48dc-aa76-175fdebfc74f2026-05-06WarningsExact identifier
unii: O80TY208ZW
unii: 91GQH8I5F7

Reported adverse events (FAERS/openFDA)#

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