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 34 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY,INC.53fc327e-e345-26f2-e054-00144ff8d46c2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
application number: M001
CALCIUM CARBONATE CHEWABLE ANTACIDCALCIUM CARBONATEGeri-Care Pharmaceutical Corp27d9b505-08bd-4261-a59d-6ddc4031be322023-10-25WarningsExact identifier
application number: M001
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd5c123f8-1396-4d8c-96d3-e5ade96a6ef82020-11-10WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
application number: M001
Magnesium Oxide 400mgMAGNESIUM OXIDE 400MGAllegiant Health2ea68874-8c20-4284-bd0a-f07768057b832019-01-28WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health51dd53e8-22ff-4967-9124-f15c3986e4dd2017-11-17WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health551d6135-2650-4c27-a20d-d56a9aba7b712017-11-08WarningsExact 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