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
Label	Manufacturer	Effective date	Type
Cold Relief Day Plus Night	Schwabe North America, Inc. \| Universal Synergetics, Inc.	2025-07-29	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53499-2040-1	Cold ReliefDay Plus Night	5 g in 1 POUCH	Powder	5 g	1 [hp_X] in 5g	4
53499-2040-1	Cold ReliefDay Plus Night	8 in 1 PACKAGE	Powder		1 [hp_X] in 5g	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53499-2040	COLD RELIEF DAY PLUS NIGHT KIT [SCHWABE NORTH AMERICA, INC.]	3	Unmatched	20250321_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 40 of 40 · 785 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arthritis Joints	GNAPHALIUM POLYCEPHALUM, BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, BORAX, CUPRUM ACETICUM, KALI CARBONICUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, AMMONIUM MURIATICUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, GLANDULA SUPRARENALIS SUIS, MERCURIUS PRAECIPITATUS RUBER, SEPIA, ZINCUM METALLICUM, PALLADIUM METALLICUM, PICRICUM ACIDUM, SULPHUR, CARTILAGO SUIS, INTERVERTEBRAL DISC (SUIS), MEDULLA OSSIS SUIS	Deseret Biologicals, Inc.	cec46d33-e106-481a-958d-b2aedabe1879	2017-04-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Thyrotox	CHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA	BioActive Nutritional, Inc.	e229a260-13f3-4136-b325-9a8954f8a327	2016-08-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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