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 7 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratories78f11b4b-d203-45c9-9b29-2c135eb666192026-04-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
application number: M001
ndc (product): 77333-829
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
application number: M001
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
application number: M001
Dulcolax Soft Chews Mixed BerryMAGNESIUM HYDROXIDEChattem, Inc.fe71907c-b1eb-4433-9337-933a944f3e622026-03-31WarningsExact identifier
application number: M001
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
application number: M001
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
application number: M001
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
application number: M001
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact 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