FDA.reportPublic FDA data

NDC 58160-740-02 - Rotarix

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
58160-740
Requested NDC
58160-740-02
Package NDCs from labels
58160-740-02, 58160-740-21
Manufacturer
GlaxoSmithKline Biologicals SA
Effective date
2026-09-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rotarix - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-09-25VACCINE LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-740-02Rotarix1.5 mL in 1 APPLICATORSOLUTION1.531
58160-740-21Rotarix10 in 1 CARTONSOLUTION1031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-740ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]29Current NDC, 2 package rows20250327_f3182470-1965-4e20-dbaf-e3506f893ea5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-740-02ML - Milliliter58160-7400d49df46-2478-4dac-a40c-812fbaf443e912023-03-13
58160-740-21ML - Milliliter58160-740e76ff66a-10db-400b-a7cc-c728ba10af2412023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGENACTIVE INGREDIENTKZ3L01D2PCROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGENACTIVE MOIETYKZ3L01D2PCROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
CYSTINEINACTIVE INGREDIENT48TCX9A1VTROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
DEXTRAN 1INACTIVE INGREDIENTI8LHQ0D645ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
FERRIC NITRATEINACTIVE INGREDIENTN8H8402XOBROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
GLUTAMINEINACTIVE INGREDIENT0RH81L854JROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
PHENOLSULFONPHTHALEININACTIVE INGREDIENTI6G9Y0J1OJROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
SODIUM PYRUVATEINACTIVE INGREDIENTPOD38AIF08ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
SORBITOLINACTIVE INGREDIENT506T60A25RROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
SUCROSEINACTIVE INGREDIENTC151H8M554ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13
TYROSINEINACTIVE INGREDIENT42HK56048UROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]13

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 1 of 87 · 1,737 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
calcium chlorideCALCIUM CHLORIDEEskayef Pharmaceuticals Limited5b0bd762-4c87-597e-e063-6394a90a83032026-09-09Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.ace1eb11-b925-405a-b772-58c60b3ca7d42026-09-09Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
unii: 8MDF5V39QO
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Kali MurKALIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a546950-3f03-7abf-e063-6294a90a19682026-08-31WarningsExact identifier
unii: 660YQ98I10
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Calcium ChlorideCALCIUM CHLORIDEREMEDYREPACK INC.801f110c-7800-4689-a37a-f31d99c0f9302026-08-28Adverse reactionsExact identifier
unii: M4I0D6VV5M
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEREMEDYREPACK INC.2c407aaf-5d95-49ff-a5db-f1d7b51903342026-08-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Calcium ChlorideCALCIUM CHLORIDE INJECTIONREMEDYREPACK INC.3089499b-142d-482e-889d-1db4da7b11522026-08-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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