FDA.reportPublic FDA data

NDC 0006-4045-01 - GARDASIL

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
0006-4045
Requested NDC
0006-4045-01
Package NDCs from labels
0006-4045-01, 0006-4045-00, 0006-4045-41
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2025-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GARDASIL - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2025-04-02VACCINE LABEL
GARDASIL - A-S Medication SolutionsA-S Medication Solutions2020-01-18VACCINE 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
0006-4045-00GARDASIL1 in 1 CARTONINJECTION, SUSPENSION132
0006-4045-01GARDASIL0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION0.532
0006-4045-41GARDASIL10 in 1 CARTONINJECTION, SUSPENSION1032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4045GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]32Current NDC, Legacy NDC, 3 package rows20250416_30952400-0572-4431-9150-3a41affffb9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4045-00ML - Milliliter0006-4045ed901cd8-6c1f-4d8e-b9af-58df37e333ee12013-02-13
0006-4045-01ML - Milliliter0006-404508590ade-52ba-471f-8a61-014f9a303d4e12013-02-13
0006-4045-41ML - Milliliter0006-4045b6f6293d-bed0-4776-98f6-e4e65b2e31e712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGENACTIVE INGREDIENTZ845VHQ61PGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGENACTIVE INGREDIENT6LTE2DNX63GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGENACTIVE INGREDIENTJ2D279PEM5GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGENACTIVE INGREDIENT61746O90DYGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGENACTIVE MOIETYZ845VHQ61PGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGENACTIVE MOIETY6LTE2DNX63GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGENACTIVE MOIETYJ2D279PEM5GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGENACTIVE MOIETY61746O90DYGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
HISTIDINEINACTIVE INGREDIENT4QD397987EGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23
WATERINACTIVE INGREDIENT059QF0KO0RGARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6, 11, 16, AND 18) VACCINE, RECOMBINANT) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]23

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 8 of 56 · 1,105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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