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 13 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
TraumeelATROPA BELLADONNA,ECHINACEA, UNSPECIFIED,ARNICA MONTANA ROOT,ACONITUM NAPELLUS,BELLIS PERENNIS,CALENDULA OFFICINALIS FLOWERING TOP,CALCIUM SULFIDE,HYPERICUM PERFORATUM,COMFREY ROOT,MATRICARIA RECUTITA,HAMAMELIS VIRGINIANA LEAF,ECHINACEA PURPUREA,MERCURIUS SOLUBILIS,ACHILLEA MILLEFOLIUMMediNatura Inc39630b57-28b1-486b-a4ff-4af65324454f2026-05-21WarningsExact identifier
unii: G0R4UBI2ZZ
unii: 1MBW07J51Q
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HepaparCARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, TARAXACUM OFFICINALE, BOLDO, CHOLINUM, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUERCUS GLANDIUM SPIRITUS, AURUM MURIATICUM NATRONATUM, CHENOPODIUM ANTHELMINTICUMEnergique, Inc.ddbcbad9-ddb0-4ffd-a769-4de02e6698452026-05-19WarningsExact identifier
unii: 27YLU75U4W
Hypothalamus, Adrenal, Pituitary SarcodeBERBERIS VULGARIS, GLANDULA SUPRARENALIS (BOVINE), HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CINCHONA OFFICINALIS, PHOSPHORUSNutritional Specialties, Inc.e22cfa0b-84ed-47e4-ad82-579384fafcd62026-05-19WarningsExact identifier
unii: 27YLU75U4W
Cough and Bronchial DaytimeACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.ab0a4fd6-2311-4dd4-a146-949b86bfb4e72026-05-14WarningsExact identifier
unii: 1MBW07J51Q
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Vein GardAESCULUS HIPPOCASTANUM, APIS MELLIFICA, CARBO VEGETABILIS, CARDUUS MARIANUS, HAMAMELIS VIRGINIANA, LYCOPODIUM CLAVATUM, PULSATILLA, SEPIANaturalCare76468373-f6f6-43ec-80b2-2816a15f065b2026-05-11WarningsExact identifier
unii: I76KB35JEV
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
unii: 70FD1KFU70
unii: 1MBW07J51Q
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 3SW678MX72
unii: 451W47IQ8X
unii: G0R4UBI2ZZ
FNG IIECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, IODIUM, ADRENALINUM, ARGENTUM METALLICUM, THYMUS (SUIS), THYROIDINUM (SUIS), PHOSPHORICUM ACIDUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.d15cbfe9-051d-4aeb-a0f3-105bef7796bc2026-05-07WarningsExact identifier
unii: ZW3Z11D0JV
unii: I76KB35JEV
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GastrotoneCAPSICUM ANNUUM, FOENICULUM VULGARE, SYMPHYTUM OFFICINALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, MAGNESIA PHOSPHORICA, PULSATILLA (VULGARIS)BioActive Nutritional, Inc.1ba810f2-ee90-400c-81d7-d066c5eebe592026-05-07WarningsExact identifier
unii: I76KB35JEV
Lymph Tonic IIIECHINACEA (ANGUSTIFOLIA), BOLDO, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ARNICA MONTANA, CALCAREA IODATA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, NAJA TRIPUDIANS, CALCAREA PHOSPHORICA, NATRUM SULPHURICUM, PYROGENIUM, SULPHUR, CARCINOSIN, INFLUENZINUMBioActive Nutritional, Inc.c39a5867-6865-43ac-b36f-51cbfcbc415f2026-05-06WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q

Reported adverse events (FAERS/openFDA)#

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