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 9 of 80 · 1,591 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: G0R4UBI2ZZ
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: 91D9GV0Z28
VoiceCalmARNICA MONTANA WHOLE, ARISAEMA TRIPHYLLUM ROOT, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, TOXICODENDRON PUBESCENS LEAF, SPONGIA OFFICINALIS SKELETON, ROASTEDBoiron4b6fce7b-8a2e-b318-e063-6394a90ac2112026-03-20WarningsExact identifier
unii: O80TY208ZW
unii: 91GQH8I5F7
CHESTAL COLD AND COUGHSOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDBoiron4d7a3143-ec9d-310b-e063-6394a90ac46e2026-03-20WarningsExact identifier
unii: 91GQH8I5F7
Chamomilla Dec Cupro culta 3XCHAMOMILLA DEC CUPRO CULTA 3XUriel Pharmacy, Inc4d7af784-9f92-0dd5-e063-6394a90ab33b2026-03-20WarningsExact identifier
unii: G0R4UBI2ZZ
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
unii: 91GQH8I5F7
unii: G0R4UBI2ZZ
Lymph Tonic IIIADENOSINUM TRIPHOSPHORICUM DINATRUM, ARNICA MONTANA, BOLDO, CALCAREA IODATA, CALCAREA PHOSPHORICA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), GERMANIUM SESQUIOXIDE, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024-2025), NAJA TRIPUDIANS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SULPHUR, THYROIDINUM (SUIS), UBIDECARENONUMBioActive Nutritional, Inc.14f87aa6-2005-4939-a612-1162bbc5462b2026-03-18WarningsExact identifier
unii: O80TY208ZW
unii: 91D9GV0Z28
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 2E32821G6I
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: G0R4UBI2ZZ
Neuralgia HPAGARICUS MUSCARIUS, ALLIUM CEPA, ARNICA MONTANA, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, PHOSPHORUS, PLUMBUM METALLICUMBioActive Nutritional, Inc.9674fbbb-ab2d-412e-bf69-3bd7b6b0134b2026-03-17WarningsExact identifier
unii: O80TY208ZW
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 91D9GV0Z28
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.BM Private Limited4d22be93-c5f9-6ef3-e063-6294a90a7a8f2026-03-16WarningsExact identifier
unii: 91GQH8I5F7
BM BIO26CALC FLUOR, CALC PHOS, KALI PHOS, MAG PHOS.BM Private Limited4d2480f4-e2df-5cf0-e063-6394a90a1bde2026-03-16WarningsExact identifier
unii: 91D9GV0Z28
BM BIO7CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULF.BM Private Limited4d260c2a-9218-17d0-e063-6394a90a62b72026-03-16WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
BM BIO10CALC PHOS, FERR PHOS, KALI MUR.BM Private Limited4d271d53-5a12-3567-e063-6294a90a37572026-03-16WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7
BM BIO 19FERR PHOS, KALI SULF, MAG PHOS, NAT SULF.BM Private Limited4d272668-946d-53d9-e063-6394a90ad5712026-03-16WarningsExact identifier
unii: 91GQH8I5F7
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 91GQH8I5F7
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.BM Private Limited4d277580-9a76-ae86-e063-6394a90a20e92026-03-16WarningsExact identifier
unii: 91D9GV0Z28
unii: 91GQH8I5F7

Reported adverse events (FAERS/openFDA)#

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