FDA.reportPublic FDA data

Rolaids Heartburn plus Gas

Product NDC
84126-343
11-digit product format
841260343
Labeler code
84126
Product ID
84126-343_5cdad163-da5c-b461-e063-6294a90a4ecf
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate, Magnesium Hydroxide, Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
Substance
DIMETHICONE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength
40; 1000; 200 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
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
Rolaids Heartburn plus Gas
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE40 mg/1
CALCIUM CARBONATE1000 mg/1
MAGNESIUM HYDROXIDE200 mg/1

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-343-01Rolaids Heartburn plus Gas10 in 1 CELLO PACKTABLET, CHEWABLE103
84126-343-03Rolaids Heartburn plus Gas10 in 1 CELLO PACKTABLET, CHEWABLE103
84126-343-03Rolaids Heartburn plus Gas3 in 1 PACKAGETABLET, CHEWABLE33
84126-343-60Rolaids Heartburn plus Gas60 in 1 BOTTLETABLET, CHEWABLE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-343ROLAIDS HEARTBURN PLUS GAS (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 4 package rows20241220_2991f04c-7f02-df60-e063-6394a90a927c.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 33 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONECARDINAL HEALTH7ee3618a-43c8-2ccc-e053-2a91aa0a81152023-11-07WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
application number: M001
ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHaf5ea189-2118-4ffd-e053-2995a90aecfd2023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECARDINAL HEALTHb1a3cef7-a05e-bb39-e053-2995a90abfb52023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa9654a96-9bfd-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEH E Babfe6688-f852-ba8e-e053-2995a90a49a32023-11-07WarningsExact identifier
application number: M001
ANTACID AND GASRELIEFALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGOODSENSEa9654a96-9bf9-60ea-e053-2995a90ae38d2023-11-07WarningsExact identifier
application number: M001
ADVANCED ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGOODSENSEa964da1d-e1e3-94a8-e053-2a95a90ac8042023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEKROGER COMPANYa1b132d5-00d0-55c1-e053-2a95a90a8d272023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e5fc3f-caf0-84c4-e053-2a95a90af6552023-11-07WarningsExact identifier
application number: M001
ANTACID PLUSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS LLCb8e233c7-eaa0-b1ec-e053-2a95a90a05492023-11-07WarningsExact identifier
application number: M001
Antacid PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEBETTER LIVING BRANDS, LLCb93191e8-28a7-6c8f-e053-2995a90ac3272023-11-07WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ADVANCED ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEDOLGENCORP, LLCb6993a5a-6144-ba65-e053-2995a90aee9b2023-11-07WarningsExact identifier
application number: M001
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONb4656a2f-a866-5f7a-e053-2995a90ac2c22023-11-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association9f410b3a-5579-4fae-84b1-5cd35563451e2023-11-06WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEChain Drug Marketing Association60de23d0-6e75-3b97-e053-2a91aa0aea5e2023-11-06WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEMAJOR Pharmaceuticals Inc.536b143d-a1d7-4972-a90b-248e419370702023-11-02WarningsExact identifier
application number: M001
ALMACONE DOUBLE STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIES25f22cff-2864-4853-a7f8-8edd9f8f3c292023-11-02WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e8215a4-0136-bfdd-e053-2991aa0a5ddf2023-11-01WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e946ed2-819e-fb40-e053-2991aa0a6f772023-11-01WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649510calcium carbonate 1000 MG / magnesium hydroxide 200 MG / simethicone 40 MG Chewable TabletPSN2991f04c-7f02-df60-e063-6394a90a927c3
1649510calcium carbonate 1000 MG / magnesium hydroxide 200 MG / simethicone 40 MG Chewable TabletSCD2991f04c-7f02-df60-e063-6394a90a927c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-343-018412603430110 TABLET, CHEWABLE in 1 CELLO PACK (84126-343-01) 2024-12-06NoNoCurrent
84126-343-03841260343033 CELLO PACK in 1 PACKAGE (84126-343-03) / 10 TABLET, CHEWABLE in 1 CELLO PACK3 cello pack2024-12-06NoNoCurrent
84126-343-608412603436060 TABLET, CHEWABLE in 1 BOTTLE (84126-343-60) 2024-12-06NoNoCurrent