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 43 of 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rashes-HivesANTIMON. CRUD., APIS MEL., ARSENICUM ALB., BERBER. VULG., BOVISTA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTON, DULCAMARA, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM, MEZEREUM, NUX VOM., PETROLEUM, PULEX IRRITANS, PULSATILLA, RHUS TOXICODENDRON, SARSAPARILLA, SULPHUR, ECHINACEA, RUMEX CRISP., TARAXACUM, URTICA UR.Newton Laboratories, Inc.9988c585-381d-1ec5-e053-2995a90a12022025-09-29WarningsExact identifier
unii: 9N1RM2S62C
unii: T7J046YI2B
unii: I76KB35JEV
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Panic EaseACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9971a152-0706-8166-e053-2995a90aab9f2025-09-23WarningsExact identifier
unii: 27YLU75U4W
unii: 91GQH8I5F7
unii: T7J046YI2B
Degex LiquescenceTHUJA OCCIDENTALIS, UBIDECARENONUM, CONIUM MACULATUM, ASTERIAS RUBENS, GERMANIUM METALLICUM, LACHESIS MUTUS, BUFO RANA, CARCINOSIN, PHOSPHORUSNutritional Specialties, Inc.4bbd4d0b-fd30-4985-a04e-3066ed0d1f622025-09-23WarningsExact identifier
unii: 27YLU75U4W
Blood LiquescenceALLIUM CEPA, HYSSOPUS OFFICINALIS, AVENA SATIVA, PALOONDO, URTICA DIOICA, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALE, CAPSICUM ANNUUM, HEPAR (BOVINE), HYPOPHYSIS SUIS, JUGLANS REGIA, MEDULLA OSSIS SUIS, REMEX CRISPUS, SPLEEN (BOVINE), CAMPHORA, MAGNESIA PHOSPHORICA, FERRUM PHOSPHORICUM, PYROGENIUMNutritional Specialties, Inc.42f57741-8d47-4e50-a8fb-adfc73453ed22025-09-22WarningsExact identifier
unii: 9N1RM2S62C
unii: 91GQH8I5F7
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.3f2b75d8-89f1-8d67-e063-6294a90a01662025-09-19WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c334fbd-0c1e-eac0-e053-2995a90a92832025-09-19WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
LibidoHYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, AGNUS CASTUS, ARALIA QUINQUEFOLIA, BARYTA CARBONICA, BERBERIS VULGARIS, BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CAUSTICUM, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CONIUM MACULATUM, GAULTHERIA PROCUMBENS, GRAPHITES, KALI CARBONICUM, LYCOPODIUM CLAVATUM, NUX VOMICA, ONOSMODIUM VIRGINIANUM, PHOSPHORUS, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9c348fa7-1d68-4975-e053-2995a90a0ca62025-09-19WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
I-SleepABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANANewton Laboratories, Inc.c6f053fe-8b59-7226-e053-2995a90a80932025-09-18WarningsExact identifier
unii: T7J046YI2B
unii: I76KB35JEV
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 27YLU75U4W
unii: T7J046YI2B
unii: I76KB35JEV
Plantago PyritePLANTAGO PYRITEUriel Pharmacy Inc.ce4ca5f0-1760-400a-b9bb-6efa3420ba192025-09-16WarningsExact identifier
unii: 91GQH8I5F7
unii: T7J046YI2B
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
Antimonium tartaricumANTIMONY POTASSIUM TARTRATEWashington Homeopathic Products3e89179f-2597-bca0-e063-6394a90a5b072025-09-11WarningsExact identifier
unii: DL6OZ476V3
Cold Flu Relief BerryCOLD FLU RELIEF BERRYSchwabe North America03241f9f-8188-48ed-9177-42ef1e6c0fd62025-09-10WarningsExact identifier
unii: 27YLU75U4W
unii: 62I3C8233L
unii: T7J046YI2B
Oasis TEARS PF PLUS Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.5d080191-423d-4c0a-b5ae-2ccf5c4a67cb2025-09-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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