FDA.reportPublic FDA data

NDC 54973-3379-01 - 4 Kids Cold and Cough Day and Night Grape Flavor

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
54973-3379
Requested NDC
54973-3379-01
Package NDCs from labels
54973-3379-1, 54973-3379-01
Manufacturer
Hyland's Inc.
Effective date
2025-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyland's Kids Cold 'n Cough Day & Night Combo Pack Grape FlavorHyland's Inc.2025-12-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3243-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONLIQUID6 [hp_X] in 1mL11
54973-3377-14 Kids Cold and Cough Day and Night Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL11
54973-3379-14 Kids Cold and Cough Day and Night Grape Flavor1 in 1 CARTONKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33794 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [HYLAND'S INC.]7Current NDC, Legacy NDC, 5 package rows20250502_79f26bb5-15ad-e40a-e053-2991aa0aaab3.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 44 of 160 · 3,182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CirculopathADENOSINUM CYCLOPHOSPHORICUM, ARNICA MONTANA, AURUM MURIATICUM, BARYTA MURIATICA, BORAGO OFFICINALIS, CHOLESTERINUM, CITRUS LIMONUM, HYPOTHALAMUS (BOVINE), KALI IODATUM, LAUROCERASUS, MAGNESIA MURIATICA, NADIDUM, PHASEOLUS, PHOSPHORUS, THYROIDINUM (BOVINE)Energetix Corporation448d5ea0-ca41-487a-8321-38b1667764bd2025-12-17WarningsExact identifier
unii: 27YLU75U4W
GB-ToneAMMI VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUMEnergetix Corporation1d857ae7-ad24-4f3b-8c33-f52851fa1ce62025-12-17WarningsExact identifier
unii: ZW3Z11D0JV
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: 3SW678MX72
unii: 451W47IQ8X
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: 70FD1KFU70
unii: G0R4UBI2ZZ
Walgreens Black Elderberry Cold and Flu ReliefBRYONIA ALBA, GELSEMIUM SEMPERVIRENS, SAMBUCUS NIGRA, SULPHUR, ZINCUM GLUCONICUMWalgreen Co.d66d2e55-b76b-f88c-e053-2995a90a6e132025-12-17WarningsExact identifier
unii: 70FD1KFU70
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

Reported adverse events (FAERS/openFDA)#

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