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 5 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
Monobasic Sodium Phosphate and Dibasic Sodium PhosphateMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATELupin Pharmaceuticals,Inc.e2fcc382-6fac-4438-ad02-ebc8528dd59a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: C151H8M554
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: C151H8M554
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 593YOG76RN
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
RejuvesolSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATECitra Labs, LLCbc06c40f-81a0-45e5-80b6-61f67d4450682023-02-14WarningsExact identifier
unii: 593YOG76RN
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

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