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 1 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 1Q73Q2JULR
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 1Q73Q2JULR
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 1Q73Q2JULR
unii: 593YOG76RN
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 593YOG76RN
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 593YOG76RN
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
SODIUM PHOSPHATESSODIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USAc968f70b-a670-4aef-a7e0-89468ad62d9c2026-03-12Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
SODIUM PHOSPHATESSODIUM PHOSPHATESCaplin Steriles Limited46de992b-5fc8-4dad-8d95-77938decb67e2026-03-10Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

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