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 38 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Female Formula 2068FEMALE FORMULAProfessional Complementary Health Formulase8d3990e-137c-4ae0-a702-7e50552c42942026-01-08WarningsExact identifier
unii: 2788Z9758H
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
unii: 1MBW07J51Q
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: 27YLU75U4W
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Injury Drops 2034INJURY DROPSProfessional Complementary Health Formulas024011a0-6471-4016-86d4-19eeb21f0d822026-01-08WarningsExact identifier
unii: 27YLU75U4W
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: 70FD1KFU70
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
Cough Drops 2014COUGH DROPSProfessional Complementary Health Formulas533c8124-d8bc-404a-9f1f-680d7ef8eb362026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Anti-Inflammation Drops 2005ANTI-INFLAMMATION DROPSProfessional Complementary Health Formulas66c901e0-9489-423b-98ef-c9fc517b5bd22026-01-08WarningsExact identifier
unii: 1MBW07J51Q
Aesculus Combination 9202AESCULUS COMBINATIONProfessional Complementary Health Formulas5318d83a-2d8f-4ecc-80ac-d191be5f198f2026-01-08WarningsExact identifier
unii: 70FD1KFU70
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Proactiv Clean Mineral Acne CleanserSULFURAlchemee, LLC380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
unii: 70FD1KFU70
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ff95b833-3760-4e34-9636-90b423fc0d7b2026-01-07WarningsExact identifier
unii: 27YLU75U4W
unii: ZW3Z11D0JV
unii: 70FD1KFU70
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: ZW3Z11D0JV
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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