FDA.reportPublic FDA data

NDC 54973-4113-01 - Kids Cough and Mucus Daytime 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
54973-4113
Requested NDC
54973-4113-01
Package NDCs from labels
54973-4113-1, 54973-4113-01
Manufacturer
Hyland's Consumer Health Inc. | Hyland's INC
Effective date
2024-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CITRIC ACID MONOHYDRATE - Hyland's Consumer Health Inc. | Hyland's INCHyland's Consumer Health Inc. | Hyland's INC2024-04-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor1 in 1 CARTONLIQUID13
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4113KIDS COUGH AND MUCUS DAYTIME GRAPE FLAVOR (BRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S CONSUMER HEALTH INC.]3Current NDC, Legacy NDC, 2 package rows20240425_e72c8fdb-2679-86b3-e053-2a95a90a6cdf.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 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: 27YLU75U4W
unii: 91GQH8I5F7
unii: T7J046YI2B
unii: I76KB35JEV
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: T7J046YI2B
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
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
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
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: 1MBW07J51Q
ACNENICCOLUM SULPHURICUM, KALI BROMATUM, ZINCUM OXYDATUM, HEPAR SULPHURIS CALCAREUM, SULPHUR.PLYMOUTH HEALTHCARE PRODUCTS LLC6cdd54fa-6997-48da-8209-86e530f83c612025-11-20WarningsExact identifier
unii: 1MBW07J51Q
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
unii: DL6OZ476V3
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: 91GQH8I5F7
unii: T7J046YI2B
unii: I76KB35JEV
Liver LiquescenceCARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, UVA URSI, RAPHANUS SATIVUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, HYDRASTIS CANADENSIS, GALLBLADDER (BOVINE), HEPAR (BOVINE), BETA VULGARIS, PHOSPHORUSNutritional Specialties, Inc.84f9c2f6-cda2-4cfd-8485-7713806d705c2025-11-19WarningsExact identifier
unii: 27YLU75U4W
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: 27YLU75U4W
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Antifungal creamANTIFUNGAL CREAMGuangzhou Guoyoumi Biotechnology Co Ltd43a5b3c8-3b99-b113-e063-6394a90a9aff2025-11-15WarningsExact identifier
unii: PDC6A3C0OX
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
Arthritis HPAPIS MELLIFERA, BRYONIA ALBA ROOT, CAUSTICUM, COLCHICUM AUTUMNALE BULB, KALMIA LATIFOLIA LEAF, LEDUM PALUSTRE TWIG, PULSATILLA VULGARIS, RHODODENRON AUREUM LEAF, TOXICODENDREN PUBESCENS LEAFNatural Creations, Inc.3455dda6-4329-443b-8322-0b11ce7414432025-11-13WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV

Reported adverse events (FAERS/openFDA)#

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