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 4 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUTRIZEN ARNICA BRUISE RELIEF CreamPUTRIZEN ARNICA BRUISE RELIEF CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd58a805d3-9787-8396-e063-6394a90a32542026-08-09WarningsExact identifier
unii: O80TY208ZW
JetZone Jet Lag PreventionARNICA MONTANA, ANAMIRTA COCCULUS, POTASSIUM PHOSPHATE, GELSEMIUM SEMPERVIRENS, STRYCHNOS NUX VOMICA, SILVER NITRATEBelclare Corporation08f6270b-afbe-db8c-e063-6394a90a39862026-08-06WarningsExact identifier
unii: O80TY208ZW
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 91D9GV0Z28
unii: 2E32821G6I
GallbladderparCARDUUS MARIANUS, FEL TAURI, TARAXACUM OFFICINALE, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, SANGUINARIA CANADENSIS, GALLBLADDER (SUIS)Energique, Inc.1d68d6b0-a018-4450-af3c-103b976b46172026-07-31WarningsExact identifier
unii: HF539G9L3Q
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: HF539G9L3Q
unii: ETJ7Z6XBU4
MUSCLE RESCUEARNICA MONTANA, RHUS TOX, PHYTOLACCA DECANDRA, PULSATILLA (VULGARIS), RUTA GRAVEOLENSPeaceful Mountain, Inc.69e74c40-7633-4935-a66a-e471324b66402026-07-30WarningsExact identifier
unii: O80TY208ZW
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: ETJ7Z6XBU4
unii: 91GQH8I5F7
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
unii: O80TY208ZW
GLP-4TE HOMOAACG-A, AACG-B, ADENOSINUM CYCLOPHOSPHORICUM, BERBERINUM, CALCAREA CARBONICA, CINCHONA OFFICINALIS, CHOLINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, CURCUMA LONGA, METHYLCOBALAMIN, DNA, FERRUM METALLICUM, PANAX GINSENG, L-GLUTAMIC ACID, HEPAR SUIS, HYPOTHALAMUS SUIS, INDOLUM, INSULINUM (HUMAN), IODIUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, L-METHIONINE, PANCREAS SUIS, STOMACH (SUIS), ZINCUM METALLICUM, 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATEDeseret Biologicals, Inc.bb41a08a-e960-4364-a547-4ad356b2c36d2026-07-24WarningsExact identifier
unii: 2E32821G6I
Cough and Bronchial NighttimeACONITUM NAPELLUS, ALFALFA, ARABICA COFFEE BEAN, MEDICAGO SATIVA LEAF, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.31445469-8f7f-4729-8128-fc53d5e5ab062026-07-22WarningsExact identifier
unii: 3SW678MX72
Arnicare ArthritisARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAFLaboratoires Boironcb02378b-617d-4268-b565-4136e50009f42026-07-21Exact identifier
unii: O80TY208ZW
unii: G0R4UBI2ZZ
Arnica Aurum 20/30ARNICA AURUM 20/30Uriel Pharmacy Inc.bf5c7dfe-ffc1-43f2-b00d-92fa7b014bea2026-07-21WarningsExact identifier
unii: O80TY208ZW
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
unii: O80TY208ZW
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
unii: O80TY208ZW
Arnicare Leg CrampsARNICA MONTANA WHOLE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA TOP, CLAVICEPS PURPUREA SCLEROTIUMLaboratoires Boiron051a4e17-c665-ec4d-e063-6294a90aabe62026-07-20Exact identifier
unii: O80TY208ZW
unii: HF539G9L3Q
ARNICAARNICA MONTANAHyland's Inc.85fcf1c8-6f89-4862-85a8-4983cbea28f42026-07-16WarningsExact identifier
unii: O80TY208ZW
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: O80TY208ZW
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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