FDA.reportPublic FDA data

NDC 77333-831-25 - Sodium Bicarbonate 10 GR. (650 MG)

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
77333-831
Requested NDC
77333-831-25
Package NDCs from labels
77333-831-25, 77333-831-10
Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2024-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Bicarbonate 10 GR. (650 MG) - Gendose Pharmaceuticals, LLCGendose Pharmaceuticals, LLC2024-01-08HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77333-831-102024-05-02C16284748780-11030e365-66ce-111a-e063-dadaa90a10e2GENDOSE - Sodium Bicarbonate 10 gr (650 mg) TABLETS (77333-831)
77333-831-102024-01-30C16284748780-11030e365-66ce-111a-e063-dadaa90a10e2GENDOSE - Sodium Bicarbonate 10 gr (650 mg) TABLETS (77333-831)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-831-10Sodium Bicarbonate10 GR. (650 MG)100 in 1 BOXTABLET1003
77333-831-25Sodium Bicarbonate10 GR. (650 MG)1 in 1 BLISTER PACKTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-831SODIUM BICARBONATE 10 GR. (650 MG) (SODIUM BICARBONATE) TABLET [GENDOSE PHARMACEUTICALS, LLC]3Legacy NDC, 2 package rows20240504_ee90d829-9f1f-52ae-e053-2995a90a29ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-831-10EA - Each77333-831bea49102-7fce-4a53-aa2c-6730243462f312022-12-07
77333-831-25EA - Each77333-831c00fb374-0c7b-446e-a2de-8ccd9df55b0612022-12-07

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 17 · 325 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
unii: T5L8T28FGP
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
unii: T5L8T28FGP
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
unii: T5L8T28FGP
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
unii: T5L8T28FGP
D-D SUDIUM BICARBONATE U.S.P. BICARBONATO DE SODA PUROSODIUM BICARBONATEEvi Labs485f9eb1-6535-c47c-e063-6394a90ae32c2026-01-14WarningsExact identifier
unii: 8MDF5V39QO
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
unii: T5L8T28FGP
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
unii: T5L8T28FGP
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
unii: 8MDF5V39QO
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
unii: T5L8T28FGP
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
unii: 8MDF5V39QO
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
unii: 8MDF5V39QO
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
unii: 8MDF5V39QO
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
rxcui: 198861
unii: 8MDF5V39QO
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
unii: 8MDF5V39QO
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
unii: T5L8T28FGP
SODIUM BICARBONATESODIUM BICARBONATEProPharma Distribution3867f743-c2cf-a646-e063-6394a90a82e12025-12-18Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
After Bite AdvancedSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands223d1de8-7940-bbdc-e063-6294a90a51d82025-12-18WarningsExact identifier
unii: 8MDF5V39QO
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 8MDF5V39QO
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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