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 7 of 104 · 2,071 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM82 DROPSBETA VULG, BRYONIA, CALCAREA CARB, CAUSTICUM, HELLIBOR, IODIUM, LYCOPODIUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro54119432-912d-7ae1-e063-6294a90a850c2026-06-12WarningsExact identifier
unii: 2E32821G6I
BM BM96 DROPSAGRAPHIS NUTANS, HYDRASTIS CAN, BARYTA IOD., BARYTA MUR., CALCAREA IOD., CALCAREA PHOS., CISTUS CANTotal Operations Management LLC DBA:Bestmade Natural Products Micro5411ad88-bc3a-0563-e063-6294a90a28302026-06-12WarningsExact identifier
unii: 91D9GV0Z28
BM BM19 DROPSADONIS VERN., CALC. CARB. H., FUCUS VES, GRAPHITE, PHYTOLACCA BERBM Private Limited53f78460-09ba-e41c-e063-6394a90a04232026-06-11WarningsExact identifier
unii: 2E32821G6I
BM BM43 DROPSCHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MARBM Private Limited53f8e154-d647-0064-e063-6294a90a3f6c2026-06-11WarningsExact identifier
unii: G0R4UBI2ZZ
BM BM71 DROPSBARYTA CARB, BARYTA MUR, CALC CARB, CHINA SULPH, CIMICIFUGA, FERRUM PICRICUM, CARBO VEG, CHINA OFF.BM Private Limited53fa5f30-db87-1b1b-e063-6294a90a189f2026-06-11WarningsExact identifier
unii: 2E32821G6I
BM BM82 DROPSBETA VULG, BRYONIA, CALCAREA CARB, CAUSTICUM, HELLIBOR, IODIUM, LYCOPODIUMBM Private Limited5400ca1c-2a7f-0945-e063-6394a90aeeab2026-06-11WarningsExact identifier
unii: 2E32821G6I
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBBM Private Limited53e7d586-805b-f1b3-e063-6294a90a118d2026-06-10WarningsExact identifier
unii: 3SW678MX72
Jacksons Cell Salts 5 IN 1 PHOSCALC PHOS, FERRUM PHOS , KALI PHOS, MAG PHOS, NAT PHOSZettl Health Inc.53e85f92-5863-82f1-e063-6394a90af52e2026-06-10WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: 91GQH8I5F7
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Arnica 20ARNICA 20Uriel Pharmacy, Inc2c90268b-b109-2f14-e063-6294a90a54bc2026-06-10WarningsExact identifier
unii: O80TY208ZW
Velloryn ARNICA BRUISE RELIEF CreamVELLORYN ARNICA BRUISE RELIEF CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd53f0f622-7021-56c2-e063-6294a90aea712026-06-10WarningsExact identifier
unii: O80TY208ZW
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: ETJ7Z6XBU4
unii: 91GQH8I5F7
BM BIO15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, MAG PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d242d4-c900-f0aa-e063-6394a90a80c52026-06-09WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: 91GQH8I5F7
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 91D9GV0Z28
unii: HF539G9L3Q
unii: 91GQH8I5F7
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d39613-20bc-5877-e063-6394a90a0ee92026-06-09WarningsExact identifier
unii: 91GQH8I5F7
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO 19FERR PHOS, KALI SULF, MAG PHOS, NAT SULF.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d40c16-b2a5-2666-e063-6294a90af2d22026-06-09WarningsExact identifier
unii: HF539G9L3Q
unii: 91GQH8I5F7
BM BM27ARNICA MONT, CROCUS SAT., HAMAMELIS, MILLEFOLIUM, SANGUINARIA, SECALE CORN, TRILLIUM PENDBM Private Limited53d4e5be-b144-4cbf-e063-6394a90aa6882026-06-09WarningsExact identifier
unii: O80TY208ZW

Reported adverse events (FAERS/openFDA)#

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