NDC 58160-855-01 - Arepanrix

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: 58160-855
Requested NDC: 58160-855-01
Package NDCs from labels: 58160-855-01, 58160-855-19
Manufacturer: GlaxoSmithKline Biologicals SA
Effective date: 2026-04-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Arepanrix - GlaxoSmithKline Biologicals SA	GlaxoSmithKline Biologicals SA	2026-04-28	VACCINE LABEL
AS03 - GlaxoSmithKline Biologicals SA	GlaxoSmithKline Biologicals SA	2025-12-31	VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58160-855-19	2024-02-10	C162847	48780-1	1030e365-6622-111a-e063-dadaa90a10e2	f136b41b-56f3-43a9-9d6a-61b2afca5b4a
58160-855-19	2024-01-30	C162847	48780-1	1030e365-6622-111a-e063-dadaa90a10e2	f136b41b-56f3-43a9-9d6a-61b2afca5b4a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58160-855-01	AS03	2.5 mL in 1 VIAL	INJECTION, SOLUTION	2.5		3
58160-855-19	AS03	10 in 1 CARTON	INJECTION, SOLUTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58160-855	AS03 INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]	2	Current NDC, Legacy NDC, 2 package rows	20240210_f136b41b-56f3-43a9-9d6a-61b2afca5b4a.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 74 of 76 · 1,503 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10
Potassium Chloride in Dextrose	POTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	45de5402-5e61-4bbd-8bbc-5e3392c9920e	2019-07-15	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Potassium Chloride	POTASSIUM CHLORIDE	BluePoint Laboratories	431ff2ef-567c-4b60-af43-f4da61febaad	2019-07-03	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE EXTENDED-RELEASE	Solco Healthcare LLC	f704b746-ab75-4484-8704-5baa94a07750	2019-04-30	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
Acid Reflux Relief	CAPSICUM, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK, SULFUR, SEPIA OFFICINALIS JUICE	Homeocare Laboratories	01ddf3ee-e925-404d-9b41-7876d5fd6634	2019-03-20	Warnings	Exact identifier unii: 70WT22SF4B
Tinnitus Relief	CINCHONA OFFICINALIS BARK,SALICYLIC ACID,QUININE SULFATE,FERRUM PHOSPHORICUM,POTASSIUM CHLORIDE,CALOMEL,ALLYLTHIOUREA,.	Homeocare Laboratories	30d67273-b9ec-4f3e-ace6-87a68325aaf1	2019-02-28	Warnings	Exact identifier unii: 660YQ98I10
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Candida	BAPTISIA TINCTORIA, ECHINACEA PURP, GLYCYRRHIZA GLABRA, ASTRAGALUS, CANDIDA ALB, BORAX, CALC CARB, KREOSOTUM, LYCOPODIUM, NUX VOM, PHOSPHORICUM AC, PULSATILLA, SEPIA, THUJA OCC, NAT PHOS, NITRICUM AC	Zorex International	c6595326-6d04-499e-9eb7-0a4cd2ba48fd	2018-12-21	Warnings	Exact identifier unii: 70WT22SF4B
Vitality Female	ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Natural Creations, Inc	679ba86d-bf84-4ded-b0bf-d55a0df9faa4	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate II	BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA	Zorex International	e5f53495-3b75-4d7c-89af-23058fb6fd05	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
Potassium Chloride	POTASSIUM CHLORIDE	Novel Laboratories, Inc.	ce4d4d39-8551-4789-8347-af763635922c	2018-11-28	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
WinCo Foods Saline Nasal Relief	SODIUM CHLORIDE	WinCo Foods, LLC	1280fee4-e763-49ba-8722-8cdb8157f1a4	2018-08-02	Warnings	Exact identifier unii: 451W47IQ8X
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	05dee566-7b82-4216-8a6b-765d2b4d9dc7	2018-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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