FDA.reportPublic FDA data

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 31 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Female Balance Liquescence 3009FEMALE BALANCE LIQUESCENCEProfessional Complementary Health Formulas1ed04735-32ea-4582-94e2-388e9b540cc12026-01-08WarningsExact identifier
unii: 2788Z9758H
Cerebral Blood Stim Drops 2086CEREBRAL BLOOD STIM DROPSProfessional Complementary Health Formulasee501d10-085e-4051-8702-587d4266cede2026-01-08WarningsExact identifier
unii: 27YLU75U4W
Hepar sulphuris calcareum 7120HEPAR SULPHURIS CALCAREUMProfessional Complementary Health Formulas35d52c82-5800-45ce-8fe3-53148455a2ad2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Lachesis Combination 9229LACHESIS COMBINATIONProfessional Complementary Health Formulas7301c44c-2460-43ad-9cb2-dffdc8ee423c2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Whole Body Detox Liquescence 3035WHOLE BODY DETOX LIQUESCENCEProfessional Complementary Health Formulasf69b8599-86ed-41fe-8572-b71fa9e243282026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Energy Regulation Combination 9308ENERGY REGULATION COMBINATIONProfessional Complementary Health Formulasb091febb-f18f-46d1-8bb8-d911de4c89352026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: 70FD1KFU70
Vegetable Mix 1018VEGETABLE MIXProfessional Complementary Health Formulas2c32ead6-5ee5-439f-9e7a-adf268a0cbe12026-01-08WarningsExact identifier
unii: 492225Q21H
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: 70FD1KFU70
Intestine Drops 5009INTESTINE DROPSProfessional Complementary Health Formulas51298670-06bb-4b17-a7e5-3efd91717c1a2026-01-08WarningsExact identifier
unii: ZW3Z11D0JV
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Bio ImmuneCHELIDONIUM MAJUS, LOBELIA INFLATA, RUMEX CRISPUS, SAMBUCUS NIGRA, SENEGA OFFICINALIS, SPONGIA TOSTA, TARAXACUM OFFICINALE, MYRISTICA SEBIFERA, STICTA PULMONARIA, SULPHUR, USTILAGO MAIDIS, POLYPORUS OFFICINALIS, CANDIDA ALBICANS, CARDUUS MARIANUS, CROTALUS HORRIDUS, SCROPHULARIA NODOSA, AGARICUS MUSCARIUS, BOVISTA, SECALE CORNUTUM, ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ANTHRACINUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS VULGARIS, BOTULINUM, BRYONIA (ALBA), CAMPHORA, CINCHONA OFFICINALIS,Energique, Inc.fc837264-8edd-4234-a4c7-d699fcf1b8a02026-01-08WarningsExact identifier
unii: 70FD1KFU70
Causticum Combination 9253CAUSTICUM COMBINATIONProfessional Complementary Health Formulas82b1a723-63e6-41b4-9940-a984dd719c872026-01-08WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
Pancreas DB Liquescence 3037PANCREAS DB LIQUESCENCEProfessional Complementary Health Formulas30bc86e9-538b-449a-af48-99aafc4059242026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Hypothalamus/Adrenal/Pituitary Drops 5032HYPOTHALAMUS/ADRENAL/PITUITARY DROPSProfessional Complementary Health Formulasf795b0b0-d4f9-447a-9d94-33daa3eef8e82026-01-08WarningsExact identifier
unii: 27YLU75U4W
Hyperthyroid Drops 2029HYPERTHYROID DROPSProfessional Complementary Health Formulasbe6f64dd-946b-4933-abb7-7b4c095c24902026-01-08WarningsExact identifier
unii: 27YLU75U4W
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 451W47IQ8X
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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