FDA.reportPublic FDA data

NDC 54973-3284-01 - BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME

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
54973-3284
Requested NDC
54973-3284-01
Package NDCs from labels
54973-3284-1, 54973-3284-2, 54973-3284-3, 54973-3284-01
Manufacturer
Hyland's Inc.
Effective date
2023-08-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Naturals Baby Mucus + Cold Relief Combo Pack Daytime & NighttimeHyland's Inc.2023-08-23HUMAN OTC DRUG LABEL
Hyland's Naturals Baby Mucus + Cold Relief DaytimeHyland's Inc. | Applied Laboratories, Inc.2023-08-22HUMAN OTC DRUG LABEL
Hyland's Baby Mucus Cold Relief Day and Night Value PackHyland's | Standard Homeopathic Company | Applied Laboratories, Inc. | LGM Pharma Solutions, LLC2021-07-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3284-1BABY MUCUS PLUS COLD RELIEF118 mL in 1 BOTTLE, PLASTICLIQUID11812
54973-3284-1BABY MUCUS PLUS COLD RELIEF1 in 1 CARTONLIQUID112
54973-3284-2BABY MUCUS PLUS COLD RELIEF2.5 mL in 1 POUCHLIQUID2.512
54973-3284-3BABY MUCUS PLUS COLD RELIEF148 mL in 1 BOTTLE, PLASTICLIQUID14812
54973-3284-3BABY MUCUS PLUS COLD RELIEF1 in 1 CARTONLIQUID112
54973-3284-1BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3284BABY MUCUS PLUS COLD RELIEF (BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE) LIQUID [HYLAND'S INC.]12Current NDC, Legacy NDC, 5 package rows20230823_d934cc8a-1e43-4942-858a-05b5d068679a.zip
54973-3284BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.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 3 of 200 · 3,992 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: 27YLU75U4W
unii: ETJ7Z6XBU4
unii: 70FD1KFU70
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
unii: 1MBW07J51Q
Naturasil Tinea Versicolor ReliefSULFURNature's Innovation, Inc.255f4fdb-bcc5-45e2-b9bd-06908bfbe23b2026-08-19WarningsExact identifier
unii: 70FD1KFU70
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Light Legs Heavy LegsAESCULUS HIPPOCASTANUM 3C, CARDUUS MARIANUS 3C, HAMAMELIS VIRGINIANA 3C, PULSATILLA 9CSEVENE USA55007136-0f26-0ca5-e063-6394a90a1d242026-08-18WarningsExact identifier
unii: I76KB35JEV
Comfort Down There HemorrhoidsAESCULUS HIPPOCASTANUM 5C, ALOE 5C, BERBERIS VULGARIS 3C, CAPSICUM ANNUUM 5C, CARDUUS MARIANUS 3C, NUX VOMICA 5C, PULSATILLA 9CSEVENE USA55001764-8bc9-cbac-e063-6394a90a455c2026-08-18WarningsExact identifier
unii: 269XH13919
unii: I76KB35JEV
Digest Ease Difficult DigestionBERBERIS VULGARIS 3C, CARDUUS MARIANUS 3C, CHELIDONIUM MAJUS 3C, NUX VOMICA 5C, ROBINIA PSEUDOACACIA 3C, TARAXACUM OFFICINALE 3CSEVENE USA54ffc26a-5b77-7b7d-e063-6394a90aabf42026-08-18WarningsExact identifier
unii: 269XH13919
Cold Comfort Cold and CoughALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5CSEVENE USA54e9282a-604d-4acd-e063-6394a90a59ff2026-08-18WarningsExact identifier
unii: 269XH13919
unii: 9N1RM2S62C
unii: I76KB35JEV
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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