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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
unii: 5QB0T2IUN0
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
unii: 5QB0T2IUN0
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
unii: 5QB0T2IUN0
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
unii: 5QB0T2IUN0
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
unii: 5QB0T2IUN0
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
unii: 5QB0T2IUN0
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
unii: 5QB0T2IUN0
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.74823298-d24a-4ffe-8446-1661305372b22024-12-11WarningsExact identifier
unii: 5QB0T2IUN0
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.ce2edc57-e550-4aa9-bbfe-37933913c9eb2024-12-11WarningsExact identifier
unii: 5QB0T2IUN0
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
unii: 5QB0T2IUN0
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpb8712a98-30b7-4154-a5bf-0095ef9014122024-12-09WarningsExact identifier
unii: 5QB0T2IUN0
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEGERI-CARE PHARMACEUTICALS, CORP1f1dbf41-cb87-37d4-e063-6394a90ae2942024-12-09WarningsExact identifier
unii: 5QB0T2IUN0
MAXIMUM STRENGTH AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp25c93d2a-3c48-ca3a-e063-6294a90a312e2024-12-09WarningsExact identifier
unii: 5QB0T2IUN0
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3cdfa932-6a20-2a82-e054-00144ff88e882024-12-05WarningsExact identifier
unii: 5QB0T2IUN0
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
unii: 5QB0T2IUN0
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATIONd2f8dcc2-8833-4426-9c12-1a60871451222024-10-30WarningsExact identifier
unii: 5QB0T2IUN0
Rite Aid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATERITE AID CORPORATION9889cf9e-3f6a-4abc-b723-0b295c7c8f932024-10-30WarningsExact identifier
unii: 5QB0T2IUN0
Premier Value Extra Strength Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEPHARMACY VALUE ALLIANCE, LLCe33db45a-594e-4af8-ab16-10010fc8a3882024-10-25WarningsExact identifier
unii: 5QB0T2IUN0
Mag-AL LiquidALUMINUM HYDROXIDE AND MAGNESIUM HYDROXIDEPAI Holdings, LLCb1f2d137-f5f7-4800-a1df-ef5d25544bc92024-10-08WarningsExact identifier
unii: 5QB0T2IUN0
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCbfc78d44-dc90-4f69-85af-a23dd70c68d22024-10-04WarningsExact identifier
unii: 5QB0T2IUN0

Reported adverse events (FAERS/openFDA)#

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