FDA.reportPublic FDA data

Mylanta

Product NDC
62372-520
11-digit product format
623720520
Labeler code
62372
Product ID
62372-520_19118884-2017-e86e-e063-6294a90a370c
Type
HUMAN OTC DRUG
Nonproprietary name
calcium carbonate, simethicone
Dosage form
LIQUID
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-21
Substance
CALCIUM CARBONATE; DIMETHICONE
Active strength
800; 80 mg/10mL; mg/10mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Mylanta
Brand name suffix
All-Family Multi Symptom Stomach Remedy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE800 mg/10mL
DIMETHICONE80 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2599608Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
19118884-2016-e86e-e063-6294a90a370cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-520-16MylantaAll-Family Multi Symptom Stomach Remedy473 mL in 1 BOTTLELIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-520MYLANTA ALL-FAMILY MULTI SYMPTOM STOMACH REMEDY (CALCIUM CARBONATE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.]1Current NDC, 1 package rows20240524_19118884-2016-e86e-e063-6294a90a370c.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 17 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC3ff92c9a-987f-468e-9e18-1e3e171ede142025-10-29WarningsExact identifier
application number: M001
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC35b3d9d0-b04d-4f6d-b99d-435233803d4b2025-10-29WarningsExact identifier
application number: M001
Ultra StrengthANTACID TABLETSSAFEWAY4c6cdd81-5145-4a1f-888f-85cf5d856c392025-10-29WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSSAFEWAY8ed35c3b-9878-4889-90f7-a3973cf806e02025-10-29WarningsExact identifier
application number: M001
Publix Regular Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCfd637431-7a08-4454-9cae-a68716d2d0fa2025-10-28WarningsExact identifier
application number: M001
Publix Regular Strength Peppermint FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCc41b6cc2-c852-45fd-858c-c7bedc5dc8822025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Assorted BerryCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCa270fc36-f2b2-4f56-81d4-cf165f6b5abe2025-10-28WarningsExact identifier
application number: M001
Extra Strength Sugar Free Orange Cream FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC4dbdabc4-280d-4c9a-8c54-84afc615c8c72025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Tropical FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC28e8dd03-25cf-43db-8c4d-3aae99be9d532025-10-28WarningsExact identifier
application number: M001
Publix Ultra Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC9e1c883f-016e-4c05-b27a-750d14c0f3e52025-10-28WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,48827658-02f7-4599-a90a-1543b30b9de12025-10-27WarningsExact identifier
application number: M001
Regular Strength AntacidANTACIDWal-Mart Stores,Inc.,6e7cd170-b169-4fc0-bc90-f4421bbd9fcd2025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,febe9d70-9a1f-43a9-8ad0-3134eefc69672025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,d399f927-e80b-4162-a1f1-ef6159d6f7b12025-10-27WarningsExact identifier
application number: M001
equate Sugar Free Extra Strength Antacid Orange Cream FlavorANTACIDWal-Mart Stores,Inc.,53a22b37-66af-4735-b262-15e06ad7bf762025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.841ddf88-a016-4a3c-9508-5d5702883d8f2025-10-27WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEWal-Mart Stores,Inc.,6900fabc-2299-48cf-bbda-c92649cfd0e12025-10-27WarningsExact identifier
application number: M001
equate Ultra Strength Antacid Peppermint FlavorANTACID TABLETSWal-Mart Stores,Inc.,6a18cd92-cc51-401b-9074-fbaa1afb42ac2025-10-27WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidANTACID TABLETSWal-Mart Stores,Inc.,9acdfb08-043d-48a5-95f9-54bcba733c6e2025-10-27WarningsExact identifier
application number: M001
equate Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWal-Mart Stores,Inc448d1c72-2308-4041-8ba6-dd1e0802cc472025-10-27WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599608calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral SuspensionPSNa70f113d-d5a3-44f5-b223-cd1b0e159e1a2
2599608calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCDa70f113d-d5a3-44f5-b223-cd1b0e159e1a2
2599608calcium carbonate 80 MG/mL / simethicone 8 MG/mL Oral SuspensionPSN19118884-2016-e86e-e063-6294a90a370c1
2599608calcium carbonate 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD19118884-2016-e86e-e063-6294a90a370c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62372-520-1662372052016473 mL in 1 BOTTLE (62372-520-16) 473 ml2024-05-21NoNoCurrent