FDA.reportPublic FDA data

Mylanta Vanilla Caramel

Product NDC
62372-541
11-digit product format
623720541
Labeler code
62372
Product ID
62372-541_10a66d74-74b5-3f8d-e063-6394a90a7f00
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate, magnesium hydroxide, simethicone
Dosage form
LIQUID
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-31
Substance
CALCIUM CARBONATE; DIMETHICONE; MAGNESIUM HYDROXIDE
Active strength
800; 80; 270 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], 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 Vanilla Caramel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE800 mg/10mL
DIMETHICONE80 mg/10mL
MAGNESIUM HYDROXIDE270 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup
92RU3N3Y1OInternal UNII lookup
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1788932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
10a66d74-74b4-3f8d-e063-6394a90a7f00Available 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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-541-12Mylanta Vanilla Caramel355 mL in 1 BOTTLELIQUID3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-541MYLANTA VANILLA CARAMEL (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [INFIRST HEALTHCARE INC.]1Current NDC, 1 package rows20240207_10a66d74-74b4-3f8d-e063-6394a90a7f00.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 15 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5e996df3-25a4-b259-e053-2a91aa0a43112025-11-19WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpa7d7298f-44d6-4e09-8578-7fe3112430022025-11-19WarningsExact identifier
application number: M001
GERI-MOX MAX CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp8e57bcf5-2960-4c41-8bf2-83cb1ee501682025-11-19WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGR J General Corporation6208d11d-0670-4a20-a3fc-ebc764a8e6cd2025-11-17WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
application number: M001
Antacid ChildrensCALCIUM CARBONATECVS Pharmacy08953df1-cc29-452f-bc69-b19970a1fd2e2025-11-15WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc0bb322a5-fb92-14de-e063-6294a90a4c1b2025-11-14WarningsExact identifier
application number: M001
magnesium oxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc.dc57893c-068a-37d8-e053-2a95a90aa0542025-11-14WarningsExact identifier
application number: M001
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
application number: M001
Topcare Antacid Extra Strength Assorted BerryCALCIUM CARBONATETopco Associates LLC14f6f475-32d6-4783-8dcc-1fe265902d552025-11-10WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC38c26f49-fb5e-480c-9164-bf5edcf0726b2025-11-10WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC.bb99b942-1f84-43e1-a18d-3a975cddc59e2025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Regular StrengthCALCIUM CARBONATETopco Associates LLC2606ac08-9760-4ff6-8d90-51fbb04e6ac82025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC495d97b0-d95c-46d1-a76a-56ac7f8235382025-11-08WarningsExact identifier
application number: M001
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC.73b4cda2-900a-4380-a0ae-0abfecdb72632025-11-08WarningsExact identifier
application number: M001
Topcare Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates LLC2677ca2b-b211-475e-a9c4-643fd54a744f2025-11-08WarningsExact identifier
application number: M001
TopCare Antacid CalciumCALCIUM CARBONATETopco Associates LLCb94eac38-62d0-49a2-bb49-053fda8129e22025-11-08WarningsExact identifier
application number: M001
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC04b3d397-df99-44e2-a191-6e9199b083982025-11-08WarningsExact identifier
application number: M001
topcare Antacid Calcium Ultra StrengthCALCIUM CARBONATETopco Associates LLC6e2788b3-1e33-4908-aa2c-475d69b94ee62025-11-08WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788932calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG in 10 mL Oral SuspensionPSN10a66d74-74b4-3f8d-e063-6394a90a7f001
1788932calcium carbonate 80 MG/ML / magnesium hydroxide 27 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD10a66d74-74b4-3f8d-e063-6394a90a7f001
1788932calcium carbonate 800 MG / magnesium hydroxide 270 MG / simethicone 80 MG per 10 ML Oral SuspensionSY10a66d74-74b4-3f8d-e063-6394a90a7f001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62372-541-1262372054112355 mL in 1 BOTTLE (62372-541-12) 355 ml2024-01-31NoNoCurrent