FDA.reportPublic FDA data

Kesin MAG-AL Plus XS

Product NDC
81033-007
11-digit product format
810330007
Labeler code
81033
Product ID
81033-007_515185f7-687b-8010-e063-6394a90a1439
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; DIMETHICONE, UNSPECIFIED; MAGNESIUM HYDROXIDE
Active strength
400; 40; 400 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

Additional Listing Data#

Finished product
Yes
Brand name base
Kesin MAG-AL Plus XS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/5mL
DIMETHICONE, UNSPECIFIED40 mg/5mL
MAGNESIUM HYDROXIDE400 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QB0T2IUN0, 92RU3N3Y1O, NBZ3QY004S
Rxcui237870

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
81033-007-01Kesin MAG-AL Plus XS100 in 1 CASESUSPENSION1002
81033-007-30Kesin MAG-AL Plus XS30 mL in 1 CUP, UNIT-DOSESUSPENSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-007-01ML - Milliliter81033-0077f5cd877-bcb1-4b0e-b894-0f33117cca6512026-01-08
81033-007-30ML - Milliliter81033-00734c829f7-a155-482a-b4fe-2a9d451a705012026-01-08

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 SuspensionPSN436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 80 MG/ML / magnesium hydroxide 80 MG/ML / simethicone 8 MG/ML Oral SuspensionSCD436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 2400 MG / magnesium hydroxide 2400 MG / dimethicone 240 MG per 30 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 400 MG / magnesium hydroxide 400 MG / simethicone 40 MG per 5 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2
237870aluminum hydroxide 800 MG / magnesium hydroxide 800 MG / dimethicone 80 MG per 10 ML Oral SuspensionSY436b89f7-e417-0df2-e063-6394a90a96df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-007-0181033000701100 CUP, UNIT-DOSE in 1 CASE (81033-007-01) / 30 mL in 1 CUP, UNIT-DOSE (81033-007-30) 2025-11-05NoNoCurrent
81033-007-308103300073030 mL in 1 CUP, UNIT-DOSE30 mlHistorical