NDC 54973-3375-01 - 4 Kids Cold and Cough 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
54973-3375
Requested NDC
54973-3375-01
Package NDCs from labels
54973-3375-1, 54973-3375-2, 54973-3375-3, 54973-3375-01
Manufacturer
Hyland's Consumer Health 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 Kids Cold & Cough NighttimeHyland's Consumer Health Inc. | Hyland's Inc.2025-02-06HUMAN OTC DRUG LABEL
Hyland's Naturals Kids Cold 'n Cough Combo PackHyland’s Inc. | Hyland's Inc.2023-09-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3375-14 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-14 Kids Cold and Cough Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID11811
54973-3375-24 Kids Cold and Cough Nighttime5 mL in 1 PACKETLIQUID511
54973-3375-34 Kids Cold and Cough Nighttime1 in 1 CARTONLIQUID111
54973-3375-34 Kids Cold and Cough Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID14811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33754 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.]11Current NDC, Legacy NDC, 5 package rows20250209_71e93027-33c9-6147-e053-2a95a90aaa09.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 45 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Yeast ReliefCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURWAL-MART STORES INCd96aa608-ed8a-36cd-e053-2a95a90ac2862025-12-17WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Olive-ViateTOPICAL SKIN RELIEFVitality Works, Inc.443819f6-8608-4790-a6ec-ad9d568d75ce2025-12-17WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Pediatric Earache RemedyEAR DROPSVitality Works, Inc5769ce2c-d2e1-4069-92cc-e38bee668daf2025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
TLB-MatrixJOINT BOOSTERVitality Works, Inc.828aa3c0-b7f4-4169-92f1-6ef5f358e18a2025-12-17WarningsExact identifier
unii: I76KB35JEV
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Stop RashADULT SKIN RELIEFVitality Works, Inc.eac4daac-591c-400d-a640-4440f67906712025-12-17WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
CL-NEMOTIONAL HEALTH BOOSTERVitality Works, Inc.0de1e383-f721-4d2c-a1e1-946371234b882025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Brain SuppBRAIN SUPPORTVitality Works, Inc.4be3d5f8-f974-4ed6-ba90-f0ce08a600fe2025-12-17WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: 451W47IQ8X
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
unii: I76KB35JEV
Gripe WaterGRIPE WATERVitality Works45ade734-f446-4370-e054-00144ff88e882025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ZW3Z11D0JV
Menopause HPBELLADONNA, LACHESIS MUTUS, NUX VOMICA, PULSATILLA (VULGARIS), SECALE CORNUTUM, SEPIA, USTILAGO MAIDISBioActive Nutritional, Inc.0f0aea3f-95d2-4a81-8180-cf675eeb7f622025-12-17WarningsExact identifier
unii: I76KB35JEV
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
unii: I76KB35JEV
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIANatural Creations, Inccc457f87-16c5-4a52-a234-41a12989916b2025-12-16WarningsExact identifier
unii: 27YLU75U4W
unii: 3SW678MX72
Renu Laboratories Acne Sulphur LACNE SULFUR LOTIONRenu Laboratories, LLC13de0e4c-b134-41c0-e054-00144ff88e882025-12-16WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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