FDA.reportPublic FDA data

NDC 58160-826-01 - HAVRIX

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
58160-826
Requested NDC
58160-826-01
Package NDCs from labels
58160-826-43, 58160-826-52, 58160-826-01
Manufacturer
A-S Medication Solutions
Effective date
2026-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HAVRIX - A-S Medication SolutionsA-S Medication Solutions2026-09-21VACCINE LABEL
HAVRIX - GlaxoSmithKline Biologicals SAGlaxoSmithKline Biologicals SA2026-05-14VACCINE LABEL
HAVRIX - Dispensing Solutions, Inc. | PSS World Medical, Inc.Dispensing Solutions, Inc. | PSS World Medical, Inc.2013-11-07VACCINE LABEL
HAVRIX - Dispensing Solutions, Inc.Dispensing Solutions, Inc.2011-10-07VACCINE LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58160-826-43HAVRIX1 mL in 1 SYRINGEINJECTION, SUSPENSION133
58160-826-52HAVRIX10 in 1 CARTONINJECTION, SUSPENSION1033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58160-826HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]31Current NDC, Legacy NDC, 2 package rows20250221_f9499a4d-1288-4bd3-9d59-1d72092c38cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58160-826-01ML - Milliliter58160-8263ae3a57f-5ea5-4907-b780-2290fe8d279f12013-03-03
58160-826-11ML - Milliliter58160-826ef997ed5-9946-46e9-a7ea-fa23409770ae12013-02-13
58160-826-32ML - Milliliter58160-82615695cc1-61a5-4c53-a497-dbc00d48c9f612013-03-03
58160-826-43ML - Milliliter58160-8268d5b9600-232b-44f1-8a17-67fa3ff7346b12013-03-03
58160-826-52ML - Milliliter58160-82632246bdf-8c91-4b30-9358-cef0ea8481a112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]18
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE INGREDIENT5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)ACTIVE MOIETY5BFC8LZ6LQHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0HAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHAVRIX (HEPATITIS A VACCINE) INJECTION, SUSPENSION [DISPENSING SOLUTIONS, INC.]1

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 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
unii: 5QB0T2IUN0
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
unii: 5QB0T2IUN0
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa951fa64-7775-470e-e053-2995a90aefc42024-06-10WarningsExact identifier
unii: 5QB0T2IUN0
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals,Inc.5b1f4c78-d42e-32c7-e053-2991aa0a19852024-06-04WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
unii: 5QB0T2IUN0
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
unii: 5QB0T2IUN0
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 5QB0T2IUN0
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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