FDA.reportPublic FDA data

Rolaids Ultra Strength Antacid

Product NDC
69423-829
11-digit product format
694230829
Labeler code
69423
Product ID
69423-829_5cdb0f52-e1e0-42a6-e063-6294a90a8ead
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate, Magnesium hydroxide
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
THE PROCTER & GAMBLE MANUFACTURING COMPANY
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-30
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength
1330; 235 mg/1; mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 Ultra Strength Antacid
Brand name suffix
Strawberry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1330 mg/1
MAGNESIUM HYDROXIDE235 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-829-06Rolaids Ultra Strength AntacidStrawberry1 in 1 CARTONTABLET, CHEWABLE16
69423-829-06Rolaids Ultra Strength AntacidStrawberry6 in 1 PACKAGETABLET, CHEWABLE66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-829ROLAIDS ULTRA STRENGTH ANTACID STRAWBERRY (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, 2 package rows20250412_0f8d39d7-173b-7750-e063-6394a90ade82.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 6 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antacid- Calcium CarbonateCALCIUM CARBONATEAnhui Jiuhe Health Industry Co., Ltd53518897-5387-38cf-e063-6394a90aa3e12026-06-02WarningsExact identifier
application number: M001
ACID GONE ANTACIDALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEMajor Pharmaceuticals3d353a92-92f1-4304-8895-31d39dccd88c2026-06-01WarningsExact identifier
application number: M001
Regular Strength Antacid PeppermintCALCIUM CARBONATEHyvee Inc4e5526a8-d9ad-965b-e063-6294a90a83332026-06-01WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.52e75fe4-f04f-31da-e063-6294a90a1e4f2026-05-28WarningsExact identifier
application number: M001
Humco Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc.aeaa34f6-216d-49f3-8393-c7bda96a3e322026-05-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack9875ae6b-2d91-49a3-9512-60a2b8bbccda2026-05-22WarningsExact identifier
application number: M001
Regular Strength Antacid Assorted Fruit Regular strength AntacidCALCIUM CARBONATEHyvee Inc4df2a8ee-c823-7a59-e063-6394a90ac5562026-05-19WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEHyvee Inc4cda1c1a-f5ff-5b77-e063-6294a90ad6642026-05-13WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEVitamex USA, Corp5195cab5-bdda-2ddf-e063-6394a90ac9fe2026-05-11WarningsExact identifier
application number: M001
Kesin MAG-AL PlusALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b622a-f028-df98-e063-6394a90a3eaa2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-AL Plus XSALUMINUM AND MAGNESIUM HYDROXIDE W/SIMETHICONE SUSPENSIONKesin Pharma Corporation436b89f7-e417-0df2-e063-6394a90a96df2026-05-08WarningsExact identifier
application number: M001
Kesin MAG-ALALUMINUM AND MAGNESIUM HYDROXIDE SUSPENSIONKesin Pharma Corporation42df2198-14dc-da1c-e063-6394a90a1ae62026-05-08WarningsExact identifier
application number: M001
Supreme Antacid CherryCALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS2bc4ad16-57a1-b585-e063-6394a90a57262026-05-07WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.27848ae0-3b2f-4bfe-8856-4b8de419091e2026-05-06WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.ad3e7ebe-f2a9-4305-b370-59785f5396c82026-05-06WarningsExact identifier
application number: M001
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADERc7a8c877-3e20-4910-8ea4-1714fac3ff2f2026-05-04WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
application number: M001
Extra strength gas reliefSIMETHICONEKROGER COMPANYea1c7b4c-91a1-0c1c-e053-2995a90ab8232026-04-29WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATECardinal Health 107, LLC8109dd2b-875c-40eb-82ac-d3780bc0c4372026-04-27WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack77fa8fe5-33ac-44b2-9596-5b276e9f21622026-04-24WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1607295calcium carbonate 1330 MG / magnesium hydroxide 235 MG Chewable TabletPSN0f8d39d7-173b-7750-e063-6394a90ade826
1607295calcium carbonate 1330 MG / magnesium hydroxide 235 MG Chewable TabletSCD0f8d39d7-173b-7750-e063-6394a90ade826
1607295calcium carbonate 1330 MG (Ca 535 MG) / magnesium hydroxide 235 MG (Mg 100 MG) Chewable TabletSY0f8d39d7-173b-7750-e063-6394a90ade826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-829-06694230829061 PACKAGE in 1 CARTON (69423-829-06) / 6 TABLET, CHEWABLE in 1 PACKAGE1 package2024-01-30NoNoCurrent