FDA.reportPublic FDA data

NDC 53499-2040 - 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
53499-2040
Package NDCs from labels
53499-2040-1
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
53499-2040-1Cold ReliefDay Plus Night5 g in 1 POUCHPowder5 g1 [hp_X] in 5g4
53499-2040-1Cold ReliefDay Plus Night8 in 1 PACKAGEPowder1 [hp_X] in 5g4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-2040COLD 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 12 of 40 · 785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
XIMONTH Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.4727f304-0bc7-2fee-e063-6394a90a01782025-12-30WarningsExact identifier
unii: Y9H1V576FH
ONETOOTHCLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.9a567c9e-b8ce-7bf1-e053-2995a90aff2b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
ONETOOTH CLINIC TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.bd50abcd-8a85-2923-e053-2995a90a109b2025-12-30WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: VCQ006KQ1E
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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