FDA.reportPublic FDA data

NDC 69728-0001-1 - BICARUVAS

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
69728-0001
Requested NDC
69728-0001-1
Package NDCs from labels
69728-0001-1, 69728-0001-2
Manufacturer
PROSANA DISTRIBUCIONES, S.A. DE C.V. | PROSANA DISTRIBUCIONES S.A. DE C.V.
Effective date
2015-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bicaruvas Double Action AntacidPROSANA DISTRIBUCIONES, S.A. DE C.V. | PROSANA DISTRIBUCIONES S.A. DE C.V.2015-06-10HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69728-0001-22020-01-31C16284748780-19d75b9d0-7267-f424-e053-dadaa90a57ceBicaruvas Double Action Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69728-0001-1BICARUVAS944 mL in 1 PACKETPOWDER, FOR SOLUTION9444
69728-0001-2BICARUVAS8 in 1 BOXPOWDER, FOR SOLUTION84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69728-0001BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4Legacy NDC, 2 package rows20150702_19c65683-788e-6f71-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QPBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
TARTARIC ACIDACTIVE INGREDIENTW4888I119HBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSLBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
SODIUM CATIONACTIVE MOIETYLYR4M0NH37BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
TARTARIC ACIDACTIVE MOIETYW4888I119HBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
GRAPEINACTIVE INGREDIENT6X543N684KBICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4
STEVIA LEAFINACTIVE INGREDIENT6TC6NN0876BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]4

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 2 of 45 · 892 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
unii: H0G9379FGK
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Pepcid Complete Dual Action Berry FlavorFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJones Healthcare Group - Packaging Services, Incfff07b68-02ca-438e-8d53-5b4edf5eefc52026-08-25WarningsExact identifier
unii: H0G9379FGK
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
unii: H0G9379FGK
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: H0G9379FGK
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
unii: H0G9379FGK
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: H0G9379FGK
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: H0G9379FGK
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
unii: H0G9379FGK
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Extra Strength SmoothANTACID TABLETSCVSc00204f7-c343-4451-9e0f-638ebb72f07c2026-08-13WarningsExact identifier
unii: H0G9379FGK
CVS Extra Strength SmoothCALCIUM CARBONATECVS PHARMACY70752251-02fe-4639-a4a8-afef32463c322026-08-13WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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