NDC 58160-811-43 - PEDIARIX

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
58160-811
Requested NDC
58160-811-43
Package NDCs from labels
58160-811-43, 58160-811-52
Manufacturer
A-S Medication Solutions
Effective date
2026-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PEDIARIX - A-S Medication SolutionsA-S Medication Solutions2026-09-18VACCINE LABEL
PEDIARIX - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-05-14VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-811-43PEDIARIX0.5 mL in 1 SYRINGEINJECTION, SUSPENSION0.530
58160-811-52PEDIARIX10 in 1 CARTONINJECTION, SUSPENSION1030

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-811PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]28Current NDC, Legacy NDC, 2 package rows20240601_b63c4c7d-3dbf-419d-84cc-2c1957b92be7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-811-43ML - Milliliter58160-8113c5670be-b5f7-4f83-b2f0-c7dd33d80b2112013-03-03
58160-811-52ML - Milliliter58160-811237e40e5-be1c-46bd-96a8-90c2a32819b812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT8C367IY4EYPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTI05O535NV6PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)ACTIVE INGREDIENTQSN5XO8ZSUPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTK3W1N8YP13PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENTIRH51QN26HPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE INGREDIENT9GCJ1L5D1PPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT0LVY784C09PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT23JE9KDF4RPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT459ROM8M9MPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY8C367IY4EYPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYI05O535NV6PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)ACTIVE MOIETYQSN5XO8ZSUPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYK3W1N8YP13PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETYIRH51QN26HPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGENACTIVE MOIETY9GCJ1L5D1PPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY0LVY784C09PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY23JE9KDF4RPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY459ROM8M9MPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
ALUMINUM PHOSPHATEINACTIVE INGREDIENTF92V3S521OPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
FORMALDEHYDEINACTIVE INGREDIENT1HG84L3525PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]16

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 52 · 1,024 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
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
unii: 5QB0T2IUN0
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
Kroger Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATETHE KROGER CO.,175d9f0f-266a-4dc2-865f-d1ebd4ddac512026-09-01WarningsExact identifier
unii: 5QB0T2IUN0
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
unii: 5QB0T2IUN0
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
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 5QB0T2IUN0
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 5QB0T2IUN0
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
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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