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
2025-03-17
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.2025-03-17HUMAN 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 2 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
unii: 2E32821G6I
Anti-Itch CreamANTI-ITCH CREAMBuzzie LLC596d1aae-c97e-c928-e063-6394a90a77d92026-08-19WarningsExact identifier
unii: O80TY208ZW
Winter Relief Flu and FeverACONITUM NAPELLUS 9C, ARNICA MONTANA 9C, BELLADONNA 9C, BRYONIA 9C, DULCAMARA 9C, EUCALYPTUS GLOBULUS 3C, EUPATORIUM PERFOLIATUM 9CSEVENE USA54e9a77a-9142-3cd5-e063-6294a90a6b122026-08-18WarningsExact identifier
unii: O80TY208ZW
Recover Ease Trauma - PainARNICA MONTANA 9CH, BELLIS PERENNIS 5CH, BRYONIA 9CH, CALENDULA OFFICINALIS 5CH, HYPERICUM PERFORATUM 5CH, RHUS TOXICODENDRON 9CH, RUTA GRAVEOLENS 5CHSEVENE USA54844b24-0704-b7eb-e063-6394a90a359d2026-08-18WarningsExact identifier
unii: O80TY208ZW
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
LEG CRAMPSCINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOPHyland's Consumer Health Inc.53425c3b-6117-475c-bd8c-08f05b4520782026-08-17WarningsExact identifier
unii: HF539G9L3Q
PUTRIZEN ARNICA BRUISE RELIEF CreamPUTRIZEN ARNICA BRUISE RELIEF CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5934dddd-34f0-f9b8-e063-6294a90a1bd42026-08-16WarningsExact identifier
unii: O80TY208ZW
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 91GQH8I5F7
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Carbo ChamomillaCARBO CHAMOMILLAUriel Pharmacy Inc.6bc88bd3-ffe9-46d7-e053-2a91aa0acf792026-08-14WarningsExact identifier
unii: G0R4UBI2ZZ
Calm mind Stress - Nervousness - Anxiety - ConcentrationACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9CSEVENE USA551125a8-b6ed-f9f4-e063-6294a90a4c412026-08-13WarningsExact identifier
unii: G0R4UBI2ZZ
Travel Reset Jet Lag - Motion SicknessCHAMOMILLA 9C, COCCULUS INDICUS 9C, IGNATIA AMARA 9C, IPECACUANHA 9C, LYCOPODIUM CLAVATUM 9C, TABACUM 9CSEVENE USA5511dcde-f818-07c8-e063-6294a90aebfe2026-08-13WarningsExact identifier
unii: G0R4UBI2ZZ
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 2E32821G6I
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.63ce9942-a299-4d9b-b63b-35b297472dc92026-08-13WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: 91GQH8I5F7
unii: G0R4UBI2ZZ
Hylands Leg Cramps With ArnicaACONITUM NAPELLUSHyland's Consumer Health Inc.142ea9b2-63f9-6a04-e063-6394a90a7fc92026-08-12WarningsExact identifier
unii: O80TY208ZW
Arterioforce IIBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TRIGONELLA FOENUM-GRAECUM, HYDRASTIS CANADENSIS, KALI IODATUM, ARNICA MONTANA, CACTUS GRANDIFLORUS, PROPOLIS, BARYTA CARBONICA, CONIUM MACULATUM, SECALE CORNUTUMBioActive Nutritional, Inc.ef98fbda-6815-4d0d-b07e-62ce420c4dee2026-08-11WarningsExact identifier
unii: O80TY208ZW
GLP SupportABIES NIGRA, ABROTANUM (ARTEMISIA ABROTANUM), ANTIMONIUM CRUDUM, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANTHARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, FEL TAURI, IRIS VERSICOLOR, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NUX VOMICA, PANCREAS SUIS, PHOSPHORUS, SECALE CORNUTUMDeseret Biologicals, Inc.e9d189fa-dbb5-424f-9c5a-8aafc805c5b22026-08-11WarningsExact identifier
unii: 91D9GV0Z28
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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