FDA.reportPublic FDA data

Humco Sodium Bicarbonate

Product NDC
0395-2685
11-digit product format
003952685
Labeler code
0395
Product ID
0395-2685_52ba1edd-fc9b-bb47-e063-6394a90ad9b5
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Bicarbonate
Dosage form
POWDER
Route
ORAL
Labeler
Humco Holding Group, Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-03-25
Substance
SODIUM BICARBONATE
Active strength
1000 mg/g
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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
Humco Sodium Bicarbonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BICARBONATE1000 mg/g

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
1110802Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aeaa34f6-216d-49f3-8393-c7bda96a3e32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-2685-01Humco Sodium Bicarbonate454 g in 1 BOTTLE, PLASTICPOWDER4547
0395-2685-94Humco Sodium Bicarbonate113 g in 1 BOTTLE, PLASTICPOWDER1137

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-2685-01GM - Gram0395-268532f5bba2-0f17-49f1-b62c-193c4aa5e64412014-04-03
0395-2685-94GM - Gram0395-268555901cd8-e036-4cdc-bd57-39b41b2c33a012014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOHUMCO SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [HUMCO HOLDING GROUP, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37HUMCO SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [HUMCO HOLDING GROUP, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHUMCO SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [HUMCO HOLDING GROUP, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-2685HUMCO SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [HUMCO HOLDING GROUP, INC.]5Current NDC, Legacy NDC, 2 package rows20231216_aeaa34f6-216d-49f3-8393-c7bda96a3e32.zip

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 30 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodsense Extra Strength AntacidCALCIUM CARBONATEGoodSense193a1805-9f57-29cd-e063-6394a90ab99f2024-09-13WarningsExact identifier
application number: M001
QCH Maximum Strength Antacid 516ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.1794c35a-79c5-48c2-e063-6394a90a6d292024-08-28WarningsExact identifier
application number: M001
QCH Regular Strength Antacid 509ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17947ccd-6f11-d4cd-e063-6294a90a108a2024-08-27WarningsExact identifier
application number: M001
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEChain Drug Marketing Association Inc.17dfe539-923b-e623-e063-6294a90a041f2024-08-27WarningsExact identifier
application number: M001
QCH Extra Strength Gas Relief Cherry Flavor 134CHRSIMETHICONEChain Drug Marketing Association Inc.17e3300c-3d31-b7e1-e063-6294a90af0822024-08-27WarningsExact identifier
application number: M001
Quality Choice Infants Non-staining Gas reliefSIMETHICONEChain Drug Marketing Association Inc.17e181e5-6527-54d0-e063-6294a90addc22024-08-23WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC72ac000c-90f7-42e2-88a6-740de114a9542024-08-21WarningsExact identifier
application number: M001
GDC Extra strength Alkums Antacid 127AFCALCIUM CARBONATEGuardian Drug Company1b6da4a3-cfa6-6d98-e063-6394a90a58892024-08-13WarningsExact identifier
application number: M001
Wonderbelly Maximum Strength Antacid - Sweet MintCALCIUM CARBONATEGinger Health Company17ddf76b-237a-eeee-e063-6294a90ac2052024-07-29WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Regular StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation2847e82e-203e-4976-8c4f-4a5caa75ce002024-07-09WarningsExact identifier
application number: M001
Kirkland Ultra Stregth Antacid 171ABCALCIUM CARBONATECOSTCO WHOLESALE COMPANY1bea92e8-1b94-77b0-e063-6394a90a82122024-07-08WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa951fa64-7775-470e-e053-2995a90aefc42024-06-10WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals,Inc.5b1f4c78-d42e-32c7-e053-2991aa0a19852024-06-04WarningsExact identifier
application number: M001
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONEInfirst Healthcare Inc.19118884-2016-e86e-e063-6294a90a370c2024-05-22WarningsExact identifier
application number: M001
Stomach Circle KBISMUTH SUBSALICYLATELil' Drug Store Products, Inc05e14009-b35d-4711-b6f0-89b6d060b3872024-05-06WarningsExact identifier
application number: M001
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
application number: M001
MINT ANTACID 100CALCIUM CARBONATEJHK Inc dba American Safety & First Aid2496aed6-68ec-44c4-afc9-f7fa41b2147b2024-04-24WarningsExact identifier
application number: M001
Tums Chewy Bites Assorted BerriesCALCIUM CARBONATENavajo Manufacturing Company Inc.1625c724-7ead-cc70-e063-6294a90aa5582024-04-15WarningsExact identifier
application number: M001
Gas-X Maximum Strength SoftgelsSIMETHICONEHaleon US Holdings LLC45d1e373-0717-47df-9160-619c451666f42024-04-05WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1110802sodium bicarbonate 30 MEQ per 4 oz. Oral SolutionPSNaeaa34f6-216d-49f3-8393-c7bda96a3e327
1110802sodium bicarbonate 0.25 MEQ/ML Oral SolutionSCDaeaa34f6-216d-49f3-8393-c7bda96a3e327
1110802NaHCO3 0.25 MEQ/ML Oral SolutionSYaeaa34f6-216d-49f3-8393-c7bda96a3e327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0395-2685-0100395268501454 g in 1 BOTTLE, PLASTIC (0395-2685-01) 454 g2017-11-140000-00-00NoNoCurrent
0395-2685-9400395268594113 g in 1 BOTTLE, PLASTIC (0395-2685-94) 113 g2017-11-140000-00-00NoNoCurrent