FDA.reportPublic FDA data

NDC 0006-4047-01 - RotaTeq

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
0006-4047
Requested NDC
0006-4047-01
Package NDCs from labels
0006-4047-01, 0006-4047-02, 0006-4047-41, 0006-4047-20
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RotaTeq - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-05-15VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4047-01RotaTeq2 mL in 1 TUBESOLUTION247
0006-4047-02RotaTeq1 in 1 POUCHSOLUTION147
0006-4047-20RotaTeq25 in 1 CARTONSOLUTION2547
0006-4047-41RotaTeq10 in 1 CARTONSOLUTION1047

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4047ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME LLC]42Current NDC, Legacy NDC, 4 package rows20241114_aaf3b24e-85fd-43ee-b657-2ee4df312ec3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4047-01ML - Milliliter0006-4047ae510f35-e8cc-4521-a4d1-15d64cd8a45912013-02-13
0006-4047-02ML - Milliliter0006-4047ef40289c-553c-48f6-9494-e396677319d112021-12-08
0006-4047-20ML - Milliliter0006-404730ab1b0b-884a-4502-8026-b17299e7b6fb12013-02-13
0006-4047-41ML - Milliliter0006-4047e12a2263-e33a-4d8d-9632-68b243a56bdd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGENACTIVE INGREDIENT25VC15141QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGENACTIVE INGREDIENTJU499IS53HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGENACTIVE INGREDIENT236YGP181OROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGENACTIVE INGREDIENT6334XMP4KCROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGENACTIVE INGREDIENTL1977Q86S5ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGENACTIVE MOIETY25VC15141QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGENACTIVE MOIETYJU499IS53HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGENACTIVE MOIETY236YGP181OROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGENACTIVE MOIETY6334XMP4KCROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGENACTIVE MOIETYL1977Q86S5ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
ALBUMIN BOVINEINACTIVE INGREDIENT27432CM55QROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27
SUCROSEINACTIVE INGREDIENTC151H8M554ROTATEQ (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) SOLUTION [MERCK SHARP & DOHME CORP.]27

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 3 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: 1Q73Q2JULR
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 1Q73Q2JULR
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: 1Q73Q2JULR
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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