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 2 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 1Q73Q2JULR
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 1Q73Q2JULR
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 1Q73Q2JULR
unii: 593YOG76RN
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 1Q73Q2JULR
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: 1Q73Q2JULR
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSCivica, Inc.8fd901e6-30cb-411a-b820-b9e79625ec7c2025-08-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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