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 5 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: HF539G9L3Q
unii: ETJ7Z6XBU4
unii: 2E32821G6I
unii: G0R4UBI2ZZ
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts FERR PHOS 12X 4FERRUM PHOSZettl Health Inc.5647c1be-8727-36de-e063-6294a90a376a2026-07-07Exact identifier
unii: 91GQH8I5F7
BM BM16 DROPSARNICA MONT, CACTUS GRAND, CRATAEGUS OXY, SPIGELIA, VALERIANABM Private Limited55b70ae1-e12c-df21-e063-6294a90a78d52026-07-03WarningsExact identifier
unii: O80TY208ZW
BM BM18 DROPSBELLADONNA, BELLIS PER, EUPHRASIA, FERR PHOS, PASSIFLORA, PHYSOSTIGMA, RUTA GRAVEBM Private Limited55b745c6-42b6-da4e-e063-6394a90ad6272026-07-03WarningsExact identifier
unii: 91GQH8I5F7
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: ETJ7Z6XBU4
unii: 91GQH8I5F7
Leg CrampsACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOPHyland's Inc.fa0e82d1-0806-4256-82d2-8070336fbe1d2026-06-30WarningsExact identifier
unii: O80TY208ZW
unii: HF539G9L3Q
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Arnica Bruise CreamARNICA MONTANABeautivity LLC348f3161-8abf-26d7-e063-6294a90a41dc2026-06-29WarningsExact identifier
unii: O80TY208ZW
Hermon Arnica Cream sensitive skin formula 2 ozARNICA MONTANA 1X HPUSBeautivity LLC3f9d4d78-81fc-717f-e063-6394a90a5b8a2026-06-29WarningsExact identifier
unii: O80TY208ZW
Murasaki Beauty Arnica Bruise CreamARNICA MONTANA 1.5%Excelsior Commercial Inc4340b0d2-e350-59bf-e063-6394a90aaccb2026-06-29WarningsExact identifier
unii: O80TY208ZW
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 3SW678MX72
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
ThyroparFUCUS VESICULOSUS, SPONGIA TOSTA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), BROMIUM, CALCAREA CARBONICA, GRAPHITES, IODIUM, LACHESIS MUTUS, LEVOTHYROXINUM, PULSATILLA (PRATENSIS), SELENIUM METALLICUMEnergique, Inc.fe5065b4-7332-44fc-843a-f24b1e7a44e72026-06-24WarningsExact identifier
unii: 2E32821G6I
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: G0R4UBI2ZZ
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURTotal Operations Management LLC DBA:Bestmade Natural Products Micro5460d96f-e2b1-51ff-e063-6294a90ac7822026-06-16WarningsExact identifier
unii: O80TY208ZW
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM27ARNICA MONT, CROCUS SAT., HAMAMELIS, MILLEFOLIUM, SANGUINARIA, SECALE CORN, TRILLIUM PENDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448acb4-775a-3d22-e063-6394a90a98bf2026-06-15WarningsExact identifier
unii: O80TY208ZW
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURBM Private Limited544b1ad5-71ab-18e4-e063-6394a90a86352026-06-15WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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