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 52 of 168 · 3,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Helleborus comp. AHELLEBORUS COMP. AUriel Pharmacy Inc.150e57ad-3ed7-5cc9-e063-6394a90a25fe2025-11-21WarningsExact identifier
unii: 27YLU75U4W
Agaricus PhosphorusAGARICUS PHOSPHORUSUriel Pharmacy Inc.b6431e0b-6d84-423f-a1be-6701aa848f8d2025-11-21WarningsExact identifier
unii: 27YLU75U4W
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
unii: 70FD1KFU70
CYSTOGES HPBERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CLEMATIS RECTA FLOWERING TOP, CANIS LUPUS FAMILIARIS MILK, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, SARSAPARILLA, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHYSAGRIA SEEDNatural Creations, Inc.2efe5944-7b4d-4dac-b749-971f6dd776792025-11-21WarningsExact identifier
unii: I76KB35JEV
Pneumo SarcodeTEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHURNutritional Specialties, Inc.c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d2025-11-20WarningsExact identifier
unii: 70FD1KFU70
Candida HPBAPTISIA TINCTORIA ROOT, ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACIDNatural Creations, Inc.b587a3f0-628b-41f7-8afb-2cdcd896279e2025-11-20WarningsExact identifier
unii: 2788Z9758H
unii: I76KB35JEV
Pollen DistressALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, ARUNDO MAURITANICA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, RHUS TOX, SABADILLA, SANGUINARIA CANADENSIS, URTICA URENSLiddell Laboratories, Inc.a05f7d34-9f5c-42a4-a9f5-8e62e1e860202025-11-20WarningsExact identifier
unii: 492225Q21H
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
ECZEMANICCOLUM SULPHURICUM, KALI BROMATUM, KALI MURIATICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, KALI SULPHURICUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC624d8671-43ce-46a8-87d3-d491fd9ba9132025-11-20WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
ACNENICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC6cdd54fa-6997-48da-8209-86e530f83c612025-11-20WarningsExact identifier
unii: 70FD1KFU70
unii: 1MBW07J51Q
EczemolPOTASSIUM BROMIDE, NICKEL SULFATE, AND SULFURPLYMOUTH HEALTHCARE PRODUCTS LLC981e9f3d-b608-4a5e-92f8-895b22da12f42025-11-20Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: 492225Q21H
CONGESTION HPAMMONIUM CHLORIDE, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LOBELIA INFLATA, SODIUM SULFATE, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUSNatural Creations, Inc.97164607-bc12-44cc-84e8-f2ebc0783bd92025-11-20WarningsExact identifier
unii: 27YLU75U4W
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.897a3348-4d9d-4f74-a330-d6492baa4d032025-11-20WarningsExact identifier
unii: 3SW678MX72
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
unii: 27YLU75U4W
unii: 70FD1KFU70
unii: I76KB35JEV
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 492225Q21H
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
WALGREENS EARACHE DROPSBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFURWalgreen Companyc573dc3c-992e-604d-e053-2995a90a0ff42025-11-19WarningsExact identifier
unii: 70FD1KFU70
Mercurialis CalendulaMERCURIALIS CALENDULAUriel Pharmacy Inc.f10795fb-ec47-4c0b-b7d2-644d3d3520fa2025-11-19WarningsExact identifier
unii: 492225Q21H

Reported adverse events (FAERS/openFDA)#

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