FDA.reportPublic FDA data

Mylanta Maximum Strength Vanilla Caramel Flavor

Product NDC
62372-504
11-digit product format
623720504
Labeler code
62372
Product ID
62372-504_0bb0df3b-05ce-5c5b-e063-6394a90ab91a
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid and Anti Gas Aluminum hydroxide Magnesium hydroxide and Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-21
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
800; 800; 80 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [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 Maximum Strength Vanilla Caramel Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE800 mg/10mL
MAGNESIUM HYDROXIDE800 mg/10mL
DIMETHICONE80 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QB0T2IUN0Internal UNII lookup
NBZ3QY004SInternal 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
237870Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ace5cae4-3a78-41c3-987d-59ce22dca2acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-504-12Mylanta Maximum Strength Vanilla Caramel Flavor355 mL in 1 BOTTLE, PLASTICSUSPENSION3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-504MYLANTA MAXIMUM STRENGTH VANILLA CARAMEL FLAVOR (ANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE) SUSPENSION [INFIRST HEALTHCARE INC.]4Current NDC, Legacy NDC, 1 package rows20240111_ace5cae4-3a78-41c3-987d-59ce22dca2ac.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 14 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Ultra Stregth AntacidCALCIUM CARBONATEWal-Mart Stores, Inc.cdfe5c95-3f90-4620-a618-18bac0471c3e2025-12-03WarningsExact identifier
application number: M001
Walgreens Fast Acting Heartburn Relief Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.6eae97f3-a174-4cbc-badc-777475d2f7af2025-11-26WarningsExact identifier
application number: M001
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.2981c5f7-121a-4030-86b1-559061030e7a2025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACID CALCIUM CARBONATEWALGREEN CO.14baa410-6ce3-4ddb-aac7-e2172d1506c42025-11-25WarningsExact identifier
application number: M001
Antacid Extra StrengthANTACIDWALGREEN CO.aa797e94-6560-41c9-8c71-458a1086e8412025-11-25WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEWALGREEN COMPANYd66ec376-9cac-4de5-aac8-7c6f9aa210ce2025-11-25WarningsExact identifier
application number: M001
Antacid Extra Strength WintergreenANTACIDWALGREEN CO.ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra StrengthANTACIDWALGREEN CO.09ef90c3-1fc3-48be-8071-2fa387a461752025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.6d6cecdc-646b-4c7b-b325-9423c29c57fc2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.e1b55f3a-c6d7-4374-acc7-134786a3765e2025-11-25WarningsExact identifier
application number: M001
ULTRA STRENGTH AntacidCALCIUM CARBONATEWALGREEN COa4dcf7b9-d2c3-45d3-9410-fc4d55052a3c2025-11-25WarningsExact identifier
application number: M001
FAST ACTING Heartburn ReliefALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.48c14005-811a-4868-b33e-9348455048562025-11-25WarningsExact identifier
application number: M001
Walgreens Childrens Saline LaxativeMAGNESIUM HYDROXIDEWALGREEN CO.3813ed22-cf68-4c16-9b61-c398281200792025-11-25WarningsExact identifier
application number: M001
Ultra Strength Assorted BerriesCALCIUM CARBONATESAM'S WEST INCbc619258-7451-460c-9472-95678ea82d6e2025-11-20WarningsExact identifier
application number: M001
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
application number: M001
GERI-MOX ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp03358bc7-8819-4a05-bc13-27fbf486bd262025-11-20WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCd41f0b26-5add-4045-9754-37d70d120d282025-11-20WarningsExact identifier
application number: M001
Tums Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG in 5 mL Oral SuspensionPSNace5cae4-3a78-41c3-987d-59ce22dca2ac4
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCDace5cae4-3a78-41c3-987d-59ce22dca2ac4
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSYace5cae4-3a78-41c3-987d-59ce22dca2ac4
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSYace5cae4-3a78-41c3-987d-59ce22dca2ac4
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSYace5cae4-3a78-41c3-987d-59ce22dca2ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62372-504-1262372050412355 mL in 1 BOTTLE, PLASTIC (62372-504-12) 355 ml2016-03-210000-00-00NoNoCurrent