FDA.reportPublic FDA data

Sodium Bicarbonate 10 gr. (650 mg)

Product NDC
77333-829
11-digit product format
773330829
Labeler code
77333
Product ID
77333-829_4f52483b-6426-9646-e063-6394a90a5c0b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
TABLET
Route
ORAL
Labeler
Gendose Pharmaceuticals, LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
SODIUM BICARBONATE
Active strength
650 mg/1
Pharmacologic classes
Alkalinizing Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Bicarbonate 10 gr. (650 mg)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8MDF5V39QOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198861Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a0cc46d-372e-4175-932a-065e82d8d353Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-829-10Sodium Bicarbonate 10 gr. (650 mg)100 in 1 BOX, UNIT-DOSETABLET1001
77333-829-25Sodium Bicarbonate 10 gr. (650 mg)10 in 1 BLISTER PACKTABLET101

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 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001
Omeprazole, 24/7 Life by 7-ElevenOMEPRAZOLE TABLET, DELAYED RELEASELil' Drug Store Products, Inc.36d8a272-6cca-e759-e063-6394a90a9df82026-07-08WarningsExact identifier
application number: M001
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLCf4786707-a0f7-4ba8-9656-06278d1b4b6c2026-07-07WarningsExact identifier
application number: M001
Tums UltraCALCIUM CARBONATEHaleon US Holdings LLCc544120f-15f0-48b5-88b2-d4820f180f502026-07-07WarningsExact identifier
application number: M001
Regular Strength Assorted FlavorsANTACID CALCIUM CARBONATEAKRON PHARMA INC3f7fe022-aee9-b899-e063-6394a90afb4e2026-07-07WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEPNP Pharmaceuticals Inc.5103a317-5c4a-ec96-e063-6294a90aad7e2026-07-01WarningsExact identifier
application number: M001
Rolaids MAX STRENGTH 1500CALCIUM CARBONATE, MAGNESIUM HYDROXIDETHE PROCTER & GAMBLE MANUFACTURING COMPANY47f5a78b-66b6-2e09-e063-6294a90a8ad52026-07-01WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATEDOLGENCORP, LLC4d6ebc7e-ef39-47e8-91e9-f38484329fa92026-06-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATE CHEWABLE TABLETSCVS Pharmacy. Inc.24cec2bc-cf12-b513-e063-6394a90a94472026-06-30WarningsExact identifier
application number: M001
Childrens Stomach ReliefCALCIUM CARBONATEChain Drug Marketing Association, Inc.fb47d693-72d7-4586-9855-5e833ad1406f2026-06-18WarningsExact identifier
application number: M001
Dr. Sana Alivio Digestivo UPSET STOMACHEFEFERVESCENT ANTACIDEVI LABS51b8750c-3fcf-2543-e063-6394a90a7a8f2026-06-16WarningsExact identifier
application number: M001
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
application number: M001
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198861sodium bicarbonate 650 MG Oral TabletPSN0a0cc46d-372e-4175-932a-065e82d8d3531
198861sodium bicarbonate 650 MG Oral TabletSCD0a0cc46d-372e-4175-932a-065e82d8d3531
198861NaHCO3 650 MG Oral TabletSY0a0cc46d-372e-4175-932a-065e82d8d3531
198861sodium bicarbonate 10 Grains Oral TabletSY0a0cc46d-372e-4175-932a-065e82d8d3531
198861sodium bicarbonate 648 MG Oral TabletSY0a0cc46d-372e-4175-932a-065e82d8d3531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
77333-829-1077333082910100 BLISTER PACK in 1 BOX, UNIT-DOSE (77333-829-10) / 10 TABLET in 1 BLISTER PACK (77333-829-25) 100 blister pack2026-05-01NoNoCurrent
77333-829-257733308292510 in 1 BLISTER PACKHistorical