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 6 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antacid- Calcium CarbonateCALCIUM CARBONATEAnhui Jiuhe Health Industry Co., Ltd53518897-5387-38cf-e063-6394a90aa3e12026-06-02WarningsExact identifier
application number: M001
ACID GONE ANTACIDALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEMajor Pharmaceuticals3d353a92-92f1-4304-8895-31d39dccd88c2026-06-01WarningsExact identifier
application number: M001
Regular Strength Antacid PeppermintCALCIUM CARBONATEHyvee Inc4e5526a8-d9ad-965b-e063-6294a90a83332026-06-01WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.52e75fe4-f04f-31da-e063-6294a90a1e4f2026-05-28WarningsExact identifier
application number: M001
Humco Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc.aeaa34f6-216d-49f3-8393-c7bda96a3e322026-05-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack9875ae6b-2d91-49a3-9512-60a2b8bbccda2026-05-22WarningsExact identifier
application number: M001
Regular Strength Antacid Assorted Fruit Regular strength AntacidCALCIUM CARBONATEHyvee Inc4df2a8ee-c823-7a59-e063-6394a90ac5562026-05-19WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEHyvee Inc4cda1c1a-f5ff-5b77-e063-6294a90ad6642026-05-13WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsExact identifier
application number: M001
Kesin MAG-AL PlusALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b622a-f028-df98-e063-6394a90a3eaa2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-ALALUMINUM AND MAGNESIUM HYDROXIDE SUSPENSIONKesin Pharma Corporation42df2198-14dc-da1c-e063-6394a90a1ae62026-05-08WarningsExact identifier
application number: M001
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS2bc4ad16-57a1-b585-e063-6394a90a57262026-05-07WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.27848ae0-3b2f-4bfe-8856-4b8de419091e2026-05-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.ad3e7ebe-f2a9-4305-b370-59785f5396c82026-05-06WarningsExact identifier
application number: M001
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADERc7a8c877-3e20-4910-8ea4-1714fac3ff2f2026-05-04WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
application number: M001
Extra strength gas reliefSIMETHICONEKROGER COMPANYea1c7b4c-91a1-0c1c-e053-2995a90ab8232026-04-29WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATECardinal Health 107, LLC8109dd2b-875c-40eb-82ac-d3780bc0c4372026-04-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack77fa8fe5-33ac-44b2-9596-5b276e9f21622026-04-24WarningsExact 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