FDA.reportPublic FDA data

Dr Sana Alivio Digestivo Naranja

Product NDC
84178-112
11-digit product format
841780112
Labeler code
84178
Product ID
84178-112_59d07c2d-ef12-bd32-e063-6394a90af87d
Type
HUMAN OTC DRUG
Nonproprietary name
EFFERVESCENT ANTACID
Dosage form
GRANULE, EFFERVESCENT
Route
ORAL
Labeler
EVI LABS
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-24
Substance
BICARBONATE ION
Active strength
2485 mg/5000mg
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
Dr Sana Alivio Digestivo Naranja
Brand name suffix
UPSET STOMACH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BICARBONATE ION2485 mg/5000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HN1ZRA3Q20Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59d07c2d-ef11-bd32-e063-6394a90af87dAvailable on FDA.report

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 · 678 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84178-112-018417801120112 PACKET in 1 BOX (84178-112-01) / 5000 mg in 1 PACKET12 packet2026-08-24NoNoCurrent