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
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 DaytimeHyland' Inc. | Hyland's Inc.2026-10-15HUMAN 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 5 of 80 · 1,591 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: O80TY208ZW
unii: 91GQH8I5F7
BM BM204 DROPSBARYTA CARB, CALC PHOS, IODIUM, LYCOPUS VIR, CALC CARBBM Private Limited540e177d-83e1-cf8a-e063-6394a90ad5a22026-06-12WarningsExact identifier
unii: 91D9GV0Z28
unii: 2E32821G6I
BM BM247 DROPSAMM. BROM, FUCUS VES, KALI BROM, PHYTOLACCA BERY, PULSATILLA, CALC CARBBM Private Limited540f2d3a-c27a-b74e-e063-6394a90a82ea2026-06-12WarningsExact identifier
unii: 2E32821G6I
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro540ff544-b406-70e2-e063-6394a90ae4512026-06-12WarningsExact identifier
unii: 3SW678MX72
BM BM19 DROPSADONIS VERN., CALC. CARB. H., FUCUS VES, GRAPHITE, PHYTOLACCA BERTotal Operations Management LLC DBA:Bestmade Natural Products Micro541076d6-711a-e3ba-e063-6394a90a7c912026-06-12WarningsExact identifier
unii: 2E32821G6I
BM BM43 DROPSCHAMOMILLA, CHELONE G., CINA, CINNABARIS, CUPRUM OXY. NIG., SANTONINE, TEUCRIUM MARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410d802-d6b5-1fbe-e063-6294a90a95a32026-06-12WarningsExact identifier
unii: G0R4UBI2ZZ
BM BM71 DROPSBARYTA CARB, BARYTA MUR, CALC CARB, CHINA SULPH, CIMICIFUGA, FERRUM PICRICUM, CARBO VEG, CHINA OFF.Total Operations Management LLC DBA:Bestmade Natural Products Micro5411534a-ea33-64bd-e063-6394a90a72462026-06-12WarningsExact identifier
unii: 2E32821G6I
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
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: 91GQH8I5F7
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: 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: 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: 91GQH8I5F7

Reported adverse events (FAERS/openFDA)#

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