FDA.reportPublic FDA data

Kesin MAG-AL Plus

Product NDC
81033-006
11-digit product format
810330006
Labeler code
81033
Product ID
81033-006_51516d4f-65e7-7136-e063-6294a90a8b59
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum and Magnesium Hydroxide w/Simethicone Suspension
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-05
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE, UNSPECIFIED
Active strength
200; 200; 20 mg/5mL; mg/5mL; mg/5mL
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
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
Kesin MAG-AL Plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE200 mg/5mL
MAGNESIUM HYDROXIDE200 mg/5mL
DIMETHICONE, UNSPECIFIED20 mg/5mL

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
307746Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
436b622a-f028-df98-e063-6394a90a3eaaAvailable 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
81033-006-01Kesin MAG-AL Plus100 in 1 CASESUSPENSION1002
81033-006-30Kesin MAG-AL Plus30 mL in 1 CUP, UNIT-DOSESUSPENSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-006-01ML - Milliliter81033-006fc9cea74-3ec6-4af3-b9fa-10d8722846e512026-01-08
81033-006-30ML - Milliliter81033-00641653574-df63-4427-b41d-7f48b30af98d12026-01-08

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 7 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta All-Family Multi Symptom Stomach RemedyCALCIUM CARBONATE, SIMETHICONESportpharm LLCa70f113d-d5a3-44f5-b223-cd1b0e159e1a2026-04-24WarningsExact identifier
application number: M001
Genexa Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.4f9db9dc-6b78-d123-e063-6294a90ae38d2026-04-16WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratoriesc15a5dde-6789-4491-98fd-d248a5c7f0762026-04-15WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERugby Laboratoriesbd58baac-5790-455a-9c77-2366809925792026-04-15WarningsExact identifier
application number: M001
Rugby Extra Strength AntacidCALCIUM CARBONATERugby Laboratories78f11b4b-d203-45c9-9b29-2c135eb666192026-04-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
application number: M001
Extra Strength Antacid Calcium Carbonate, 750mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24cdab48-bcc7-e66f-e063-6394a90abbd72026-04-11WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLCc22944b8-8733-4689-be0c-f320467f79ea2026-04-01WarningsExact identifier
application number: M001
Soothe childrensCALCIUM CARBONATEWalgreen Company0235e083-5f3d-4bae-b14a-b12db623180c2026-03-31WarningsExact identifier
application number: M001
Dulcolax Soft Chews Mixed BerryMAGNESIUM HYDROXIDEChattem, Inc.fe71907c-b1eb-4433-9337-933a944f3e622026-03-31WarningsExact identifier
application number: M001
AMAZON ULTRA STRENGTH ANTACIDCALCIUM CARBONATEAMAZON.COM SERVICES LLC36cf072c-ab61-47de-8fbc-f1d1d981ec842026-03-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
application number: M001
Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEHyvee Inc44eaa023-0f11-1256-e063-6394a90a41672026-03-26WarningsExact identifier
application number: M001
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.4465441f-c518-8c1d-e063-6294a90a74072026-03-25WarningsExact identifier
application number: M001
Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEHyvee Inc44ea74ce-2b9f-e578-e063-6394a90ab72d2026-03-25WarningsExact identifier
application number: M001
Antacid MeltsCALCIUM CARBONATE 250MGQuest Products, LLC4dcc5323-eafe-0dc8-e063-6294a90acb602026-03-24WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
application number: M001
Extra Strength AntacidCALCIUM CARBONATEGrocery Outlet, Inc.44657e4a-6093-bcab-e063-6394a90a48372026-03-19WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN436b622a-f028-df98-e063-6394a90a3eaa2
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD436b622a-f028-df98-e063-6394a90a3eaa2
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY436b622a-f028-df98-e063-6394a90a3eaa2
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY436b622a-f028-df98-e063-6394a90a3eaa2
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY436b622a-f028-df98-e063-6394a90a3eaa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-006-0181033000601100 CUP, UNIT-DOSE in 1 CASE (81033-006-01) / 30 mL in 1 CUP, UNIT-DOSE (81033-006-30) 2025-11-05NoNoCurrent
81033-006-308103300063030 mL in 1 CUP, UNIT-DOSE30 mlHistorical