FDA.reportPublic FDA data

Regular Strength Antacid Antigas

Product NDC
83324-125
11-digit product format
833240125
Labeler code
83324
Product ID
83324-125_4e665cad-7d29-4f90-abfe-503996d8f800
Type
HUMAN OTC DRUG
Nonproprietary name
aluminum hydroxide, magnesium hydroxide, simethicone
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-27
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
400; 400; 40 mg/10mL; mg/10mL; mg/10mL
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
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
Regular Strength Antacid Antigas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE400 mg/10mL
MAGNESIUM HYDROXIDE400 mg/10mL
DIMETHICONE40 mg/10mL

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
17dfe539-923b-e623-e063-6294a90a041fAvailable 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-125-12Regular Strength Antacid Antigas355 mL in 1 BOTTLELIQUID3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-125REGULAR STRENGTH ANTACID ANTIGAS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC.]2Current NDC, 1 package rows20240830_17dfe539-923b-e623-e063-6294a90a041f.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 26 of 34 · 667 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
application number: M001
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid PeppermintCALCIUM CARBONATEGoodSense04950b56-7760-4b6c-8110-86b6a3f795b42024-12-19WarningsExact identifier
application number: M001
Goodsense Regular Strength Antacid PeppermintCALCIUM CARBONATEGoodSense32c04f3e-59f3-44aa-ad92-6724449827102024-12-19WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSensead4d51f6-b55b-45db-b034-fb3da54fbe992024-12-19WarningsExact identifier
application number: M001
TUMS Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
application number: M001
Goodsense Extra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSenseae6270fc-0f8d-4bba-8f12-adba3f07f7c52024-12-19WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEChain Drug Marketing Association Inc.ec729051-72d3-4d1a-8e39-d4495d5c1cf32024-12-18WarningsExact identifier
application number: M001
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATENavajo Manufacturing Company Inc.297d6703-ed4e-10d3-e063-6394a90a9f3a2024-12-17WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)RUGBY LABORATORIESf21c8cf7-45cb-492b-bf4a-462024a545692024-12-17WarningsExact identifier
application number: M001
Extra Strength Antacid Tablets, Caseys 4goodCALCIUM CARBONATE 750 MGLil' Drug Store Prodsucts, Inc.026aefd6-bb80-1ffd-e063-6394a90a12622024-12-16WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength AntacidCALCIUM CARBONATEStrategic Sourcing Services LLC1aeb60fb-eebe-4e54-be1c-4e01f3b7269c2024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Extra Strength Antacid 127AF Extra Strength Antacid Assorted FruitCALCIUM CARBONATEStrategic Sourcing Services LLC8b2fabf7-4dc6-445a-842c-b28ae081fdc82024-12-13WarningsExact identifier
application number: M001
Foster and Thrive Regular Strength Antacid PeppermintCALCIUM CARBONATEStrategic Sourcing Services LLC49d1b6c4-432b-44d3-b073-0185dbed7a902024-12-12WarningsExact identifier
application number: M001
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
application number: M001
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact 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 SuspensionPSN17dfe539-923b-e623-e063-6294a90a041f2
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD17dfe539-923b-e623-e063-6294a90a041f2
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY17dfe539-923b-e623-e063-6294a90a041f2
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY17dfe539-923b-e623-e063-6294a90a041f2
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY17dfe539-923b-e623-e063-6294a90a041f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-125-1283324012512355 mL in 1 BOTTLE (83324-125-12) 355 ml2024-08-27NoNoCurrent