FDA.reportPublic FDA data

Mylanta One Antacid/Anti-Gas

Product NDC
62372-552
11-digit product format
623720552
Labeler code
62372
Product ID
62372-552_0c4462a1-c735-c0ec-e063-6294a90a5e0c
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate, Magnesium hydroxide, Dimethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Infirst Healthcare Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-04
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
1000; 270; 80 mg/1; mg/1; mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62372-55262372-552-50DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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 One Antacid/Anti-Gas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1000 mg/1
MAGNESIUM HYDROXIDE270 mg/1
DIMETHICONE80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal 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
2556794Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed1b03f0-fabc-4c1c-8e6d-9f15c380300cAvailable 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
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
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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-552-50Mylanta One Antacid/Anti-Gas50 in 1 BOTTLE, PLASTICTABLET, CHEWABLE503
62372-552-51Mylanta One Antacid/Anti-Gas50 in 1 BOTTLETABLET, CHEWABLE503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62372-552MYLANTA ONE ANTACID/ANTI-GAS (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE) TABLET, CHEWABLE [INFIRST HEALTHCARE INC.]3Current NDC, Legacy NDC, 2 package rows20231220_ed1b03f0-fabc-4c1c-8e6d-9f15c380300c.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 6 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Calcium Carbonate 1000mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24ce4597-b571-3cbf-e063-6394a90a8ea22026-06-09WarningsExact identifier
application number: M001
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact identifier
application number: M001
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2556794calcium carbonate 1000 MG / magnesium hydroxide 270 MG / dimethicone 80 MG Chewable TabletPSNed1b03f0-fabc-4c1c-8e6d-9f15c380300c3
2556794calcium carbonate 1000 MG / magnesium hydroxide 270 MG / simethicone 80 MG Chewable TabletSCDed1b03f0-fabc-4c1c-8e6d-9f15c380300c3
2556794calcium carbonate 1000 MG / magnesium hydroxide 270 MG / dimethicone 80 MG Chewable TabletSYed1b03f0-fabc-4c1c-8e6d-9f15c380300c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62372-552-506237205525050 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (62372-552-50) 2021-05-040000-00-00NoNoCurrent
62372-552-516237205525150 TABLET, CHEWABLE in 1 BOTTLE (62372-552-51) 2021-08-160000-00-00NoNoCurrent