FDA.reportPublic FDA data

NDC 48433-107-01 - Calcium Antacid

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
48433-107
Requested NDC
48433-107-01
Package NDCs from labels
48433-107-01, 48433-107-10
Manufacturer
Safecor Health, LLC
Effective date
2023-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Calcium Antacid - Safecor Health, LLCSafecor Health, LLC2023-02-07HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-107-102023-02-16C16284748780-1d6a99b39-3364-a426-e053-dadaa90af4c2Drug Facts
48433-107-102022-01-28C16284748780-1d6a99b39-3364-a426-e053-dadaa90af4c2Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]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 8 of 45 · 885 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Antacid Assorted Fruit Regular strength AntacidCALCIUM CARBONATEHyvee Inc4df2a8ee-c823-7a59-e063-6394a90ac5562026-05-19WarningsExact identifier
application number: M001
unii: H0G9379FGK
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEHyvee Inc4cda1c1a-f5ff-5b77-e063-6294a90ad6642026-05-13WarningsExact identifier
application number: M001
rxcui: 308915
unii: H0G9379FGK
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsExact identifier
application number: M001
Kesin MAG-AL PlusALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b622a-f028-df98-e063-6394a90a3eaa2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-ALALUMINUM AND MAGNESIUM HYDROXIDE SUSPENSIONKesin Pharma Corporation42df2198-14dc-da1c-e063-6394a90a1ae62026-05-08WarningsExact identifier
application number: M001
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS2bc4ad16-57a1-b585-e063-6394a90a57262026-05-07WarningsExact identifier
application number: M001
unii: H0G9379FGK
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.27848ae0-3b2f-4bfe-8856-4b8de419091e2026-05-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.ad3e7ebe-f2a9-4305-b370-59785f5396c82026-05-06WarningsExact identifier
application number: M001
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADERc7a8c877-3e20-4910-8ea4-1714fac3ff2f2026-05-04WarningsExact identifier
application number: M001
rxcui: 308915
unii: H0G9379FGK
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
application number: M001
Extra strength gas reliefSIMETHICONEKROGER COMPANYea1c7b4c-91a1-0c1c-e053-2995a90ab8232026-04-29WarningsExact identifier
application number: M001
FolyraMULTIVITAMINOncora Pharma, LLCcb182e26-17c5-4d00-869f-08823afeeee82026-04-28Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Calcium CarbonateCALCIUM CARBONATECardinal Health 107, LLC8109dd2b-875c-40eb-82ac-d3780bc0c4372026-04-27WarningsExact identifier
application number: M001
unii: H0G9379FGK
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack77fa8fe5-33ac-44b2-9596-5b276e9f21622026-04-24WarningsExact identifier
application number: M001
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
unii: H0G9379FGK
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: H0G9379FGK
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
unii: H0G9379FGK
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
rxcui: 308915
unii: H0G9379FGK
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001

Reported adverse events (FAERS/openFDA)#

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