FDA.reportPublic FDA data

ANTACID MINT

Product NDC
63868-694
11-digit product format
638680694
Labeler code
63868
Product ID
63868-694_5b263c70-6bf5-04ca-e063-6294a90a9560
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, dimethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-01
Marketing end
2028-07-31
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
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
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
ANTACID MINT

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE200 mg/5mL
MAGNESIUM HYDROXIDE200 mg/5mL
DIMETHICONE20 mg/5mL

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
63868-694-57ANTACID MINT355 mL in 1 BOTTLESUSPENSION3553

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-694-57ML - Milliliter63868-6941b41f4f3-7f2d-430e-8a4c-3e75770ea1ea12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0ANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0ANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
HYDROXIDE IONACTIVE MOIETY9159UV381PANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8ANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1
WATERINACTIVE INGREDIENT059QF0KO0RANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-694ANTACID MINT (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]3Current NDC, Legacy NDC, 1 package rows20231107_54638c77-acad-4212-b38f-db353ed59ad2.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 2 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
application number: M001
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
application number: M001
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
application number: M001
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M001
Dr. Sana Lemon Alivio Digestivo UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59cdf417-e5c0-6bb2-e063-6294a90a9c512026-08-24WarningsExact identifier
application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59d07c2d-ef11-bd32-e063-6394a90af87d2026-08-24WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
application number: M001
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
application number: M001
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
application number: M001
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact 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 SuspensionPSN54638c77-acad-4212-b38f-db353ed59ad23
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD54638c77-acad-4212-b38f-db353ed59ad23
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY54638c77-acad-4212-b38f-db353ed59ad23
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY54638c77-acad-4212-b38f-db353ed59ad23
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY54638c77-acad-4212-b38f-db353ed59ad23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-694-5763868069457355 mL in 1 BOTTLE (63868-694-57) 355 ml2014-03-012028-07-31NoNoCurrent