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 23 of 40 · 785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Top Care Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURTopco Associates LLC2e8422f3-546a-4d09-84c0-4aa809ceaa622025-02-28WarningsExact identifier
unii: FGL3685T2X
Equaline Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURUnited Natural Foods, Inc.1178cdcf-860d-42b7-974f-346485311a2f2025-02-28WarningsExact identifier
unii: FGL3685T2X
Earache ReliefCHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHURSimilasan AGb9749db9-a2e4-4460-8769-6150285a74132025-02-28WarningsExact identifier
unii: FGL3685T2X
NOAVIA Honey beef fat creamADEPS BOVIS,CERA ALBA,MELBeijing JUNGE Technology Co., Ltd.2f057e4c-6c6b-8a85-e063-6294a90a4a0a2025-02-26WarningsExact identifier
unii: Y9H1V576FH
SiliceaSILICON DIOXIDEWashington Homeopathic Products2ee71a08-f69b-e2ef-e063-6394a90ab9902025-02-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM186ARNICA, FERR. PHOS, IGNATIA, SILICA, HYPERICUMBestmade Natural Products2e9437ae-59fa-c646-e063-6294a90ac0f62025-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
ViraClear EPs 7630 Cherry FlavorPELARGONIUM SIDOIDESSchwabe North America, Inc634cd9a1-6688-4c6b-87fd-0281a503ce622025-02-19WarningsExact identifier
unii: H6J53HEX8E
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM176ACONITE NAP, ARS ALB, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, LEDUM PAL, SULPHURBestmade Natural Products2e7e7a3c-5b60-20e2-e063-6294a90ae2892025-02-19WarningsExact identifier
unii: FGL3685T2X
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM149BERB VULG, BRYONIA ALB, CURCUMA LONGA, HYPERICUM, LYCOPODIUM, MENYANTHES, TARAXACUM, URTICA URENSBestmade Natural Products2e69eaf8-e02f-05c4-e063-6394a90a6fa02025-02-18WarningsExact identifier
unii: 856YO1Z64F
FluMisch Turmeric Kojic Acid Facial CleanserTURMERIC KOJIC ACIDBeijing JUNGE Technology Co., Ltd.2dee6804-1afd-a539-e063-6294a90a75672025-02-12WarningsExact identifier
unii: 856YO1Z64F
Bestmade Natural Products BM135ALLIUM SAT, BAPTISIA TINC, BARYTA MUR, CURCUMA LONGA, ECHINACEABestmade Natural Products2df26290-ab1d-8d5f-e063-6394a90a09c72025-02-12WarningsExact identifier
unii: 856YO1Z64F
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 6XSILICEASEVENE USAff0e0009-8bbe-e0eb-e053-6294a90afa822025-02-11WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM127CALC CARB, LYCOPODIUM, SENEGA, SILICEA, STICTA PULM, YERBA SANTABestmade Natural Products2dcc5468-9b11-b6d5-e063-6294a90a41392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 200ckSILICEASEVENE USAcf89bb22-9e2f-9143-e053-2995a90aff192025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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