NDC 0338-0328 - RECOTHROM

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: 0338-0328
Package NDCs from labels: 0338-0328-01
Manufacturer: Baxter Healthcare Corporation
Effective date: 2025-06-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
RECOTHROM - Baxter Healthcare Corporation	Baxter Healthcare Corporation	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0328-01	RECOTHROM	20 mL in 1 VIAL	POWDER, FOR SOLUTION	20 mL	1000 [iU] in 1mL	15
0338-0328-01	RECOTHROM	20 mL in 1 VIAL	POWDER, FOR SOLUTION	20 mL	1000 [iU] in 1mL	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0328	RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	12	Unmatched	20240119_54885644-e51e-4263-aadb-366abaeb56a3.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 42 of 52 · 1,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergies	APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUM	Newton Laboratories, Inc.	017f0210-195d-11d7-e063-6294a90aa750	2023-07-27	Warnings	Exact identifier unii: C151H8M554 unii: 451W47IQ8X
Melatonin Pro	CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)	Energique, Inc.	1f374642-83f7-4e64-b330-0f6ef21000a9	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
Gum Therapy	CALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUS	Deseret Biologicals	0cf8a815-808d-4018-baf9-2b4545fc7ea8	2023-07-19	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b6e33138-841a-471f-a934-c4086cbc23f6	2023-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Leaky Gut Formula	ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	8679e9ab-8610-47f1-be0e-66897f99881d	2023-07-14	Warnings	Exact identifier unii: C151H8M554
Anpituapar	HYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHIN	Energique, Inc.	c0ed2996-8eb5-43f7-b3cc-17477af7f7e9	2023-07-13	Warnings	Exact identifier unii: 451W47IQ8X
Pneumotox	TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,	BioActive Nutritional, Inc.	f8846fb1-92e5-4f8e-b3b3-bc620df90a62	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Thyrostat	FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM	Energique, Inc.	5c41b36c-e28f-4d60-b9b9-6b888d55ea95	2023-07-12	Warnings	Exact identifier unii: 451W47IQ8X
Introvert Formula	PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR	Nutritional Specialties, Inc.	522148c9-0bc0-44c9-8876-70051224c951	2023-07-11	Warnings	Exact identifier unii: 451W47IQ8X
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff5f22e1-74ee-1eee-e053-6394a90a2678	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Hypercalm-Mental Focus	CHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDE	Newton Laboratories, Inc.	ff604442-4697-e2bb-e053-6394a90a0340	2023-06-30	Warnings	Exact identifier unii: 451W47IQ8X
Natrum muriaticum	SODIUM CHLORIDE	Boiron	86455058-2722-5c0a-e053-2a91aa0ac659	2023-06-26		Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fecece1f-22bc-21dc-e053-6294a90ad0c3	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	fed03a1c-0ea8-1f8e-e053-6394a90a04c0	2023-06-23	Warnings	Exact identifier unii: 451W47IQ8X
Hyperactivity-Mental Focus	ADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORA	Newton Laboratories, Inc.	febf610e-e08a-4797-e053-6294a90a3eb5	2023-06-22	Warnings	Exact identifier unii: 451W47IQ8X
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: G2M7P15E5P
Grain and Seed Antigens	AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	BioActive Nutritional, Inc.	36ce44a5-e5ac-4eea-b76d-424dcd4e6b07	2023-06-20	Warnings	Exact identifier unii: C151H8M554 unii: 451W47IQ8X
Vital Skin Hair Nails	L-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS	Liddell Laboratories, Inc.	3e8a9233-6e65-4023-b3f8-8bca369a9c2a	2023-06-15	Warnings	Exact identifier unii: 451W47IQ8X unii: 4QD397987E
Endopar F	CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA	Energique, Inc.	d186ae0e-0dc3-48e7-9e22-6778bb80ad18	2023-06-07	Warnings	Exact identifier unii: 451W47IQ8X
good sense clearlax	POLYETHYLENE GLYCOL 3350	L. Perrigo Company	9858edef-cdb2-4ac4-8e4b-ba0720a24e41	2023-06-01	Warnings	Exact identifier unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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