FDA.reportPublic FDA data

NDC 53499-2050 - Cold Relief Day Plus Night

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
53499-2050
Package NDCs from labels
53499-2050-1
Manufacturer
Schwabe North America, Inc. | Universal Synergetics, Inc.
Effective date
2025-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cold Relief Day Plus NightSchwabe North America, Inc. | Universal Synergetics, Inc.2025-07-29HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-2050-1Cold ReliefDay Plus Night4 in 1 PACKAGEPOWDER2 [hp_X] in 5g4
53499-2050-1Cold ReliefDay Plus Night5 g in 1 POUCHPOWDER5 g2 [hp_X] in 5g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-2050COLD RELIEF DAY PLUS NIGHT KIT [SCHWABE NORTH AMERICA, INC.]3Unmatched20250321_9b063242-ffd6-48f8-af1e-14bcea5247ec.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 40 · 785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Formula 3 Cough SyrupCOUGH SYRUPVitality Works, Inc.199bbe91-ebfe-45fa-acba-62b35c7e6fba2025-12-17WarningsExact identifier
unii: H6J53HEX8E
Comfort for ColicCOMFORT FOR KIDSVitality Works, Inc.220209c1-18ab-1b78-e054-00144ff8d46c2025-12-17WarningsExact identifier
unii: FGL3685T2X
Comfort for TeethingCOMFORT FOR TEETHINGVitality Works, Inc.21b44c37-4fc8-14b4-e054-00144ff8d46c2025-12-17WarningsExact identifier
unii: FGL3685T2X
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCNatural Creations, Inc9dd6f22e-45b0-4771-80f7-6f530c96350d2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
ScarCALENDULA, GRAPHITES, HYPERICUM PERFORATUM, STAPHYSAGRIA, SILICEA, THIOSINAMINUMNatural Creations, Incf83f2234-24dc-4fb9-972e-ada049d940ed2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
SCROPHULOUS HPBARIUM CARBONATE, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, FERROUS IODIDE, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.fb30a5cf-7d25-48f3-a6e6-0cc4c1f418922025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
INJURY HPARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOTNatural Creations, Inc.10be3e95-da2f-4340-8c12-2e676472a94d2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Nursing CreamCALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ALTHAEA OFFICINALISSpry Life LLC4832b2c4-fc6b-26d6-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: FGL3685T2X
Dry Skin CareCALENDULA OFFICIALS FLOWERS, CHAMOLLIA RECUTITA FLOWERS, VIOLA TRICOLOR LEAF, SAMBUCUS NIGRA FLOWERS, TRIFOLIUM PRATENSE FLOWERS, ARCHILLEA MILLEFOLIUMSpry Life LLC48329ee2-d8df-2179-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: FGL3685T2X
Baby BalmCALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ARCHILLEA MILLEFOLIUM, SYMPHYTUM OFFICINALIS, HELIANTHUS ANNUUSSpry Life LLC48313e43-245f-5257-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: FGL3685T2X
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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