FDA.reportPublic FDA data

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
2025-02-06
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.2025-02-06HUMAN 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 4 of 80 · 1,591 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro544b2bf9-74e8-297f-e063-6394a90a3dac2026-06-15WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
KALMIAARNICA MONTANA, CHELIDONIUM, COLCHICUM, KALMIA, RANUNCULUS BULB, SANGUINARIA NIT, SUMBULTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b20-2708-1393-e063-6294a90ad8022026-06-14WarningsExact identifier
unii: O80TY208ZW
BM BM247 DROPSAMM. BROM, FUCUS VES, KALI BROM, PHYTOLACCA BERY, PULSATILLA, CALC CARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro5439a909-0395-8b6b-e063-6394a90a782e2026-06-14WarningsExact identifier
unii: 2E32821G6I
BM BM204 DROPSBARYTA CARB, CALC PHOS, IODIUM, LYCOPUS VIR, CALC CARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro543bab2a-7222-3bbe-e063-6394a90a8aae2026-06-14WarningsExact identifier
unii: 91D9GV0Z28
unii: 2E32821G6I
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: 91D9GV0Z28
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: 3SW678MX72
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: O80TY208ZW
unii: 91GQH8I5F7
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANBM Private Limited540bc176-74f3-cd39-e063-6294a90a00462026-06-12WarningsExact identifier
unii: 91D9GV0Z28
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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