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 5 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001
Omeprazole, 24/7 Life by 7-ElevenOMEPRAZOLE TABLET, DELAYED RELEASELil' Drug Store Products, Inc.36d8a272-6cca-e759-e063-6394a90a9df82026-07-08WarningsExact identifier
application number: M001
Tums UltraCALCIUM CARBONATEHaleon US Holdings LLCc544120f-15f0-48b5-88b2-d4820f180f502026-07-07WarningsExact identifier
application number: M001
Regular Strength Assorted FlavorsANTACID CALCIUM CARBONATEAKRON PHARMA INC3f7fe022-aee9-b899-e063-6394a90afb4e2026-07-07WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEPNP Pharmaceuticals Inc.5103a317-5c4a-ec96-e063-6294a90aad7e2026-07-01WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATEDOLGENCORP, LLC4d6ebc7e-ef39-47e8-91e9-f38484329fa92026-06-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATE CHEWABLE TABLETSCVS Pharmacy. Inc.24cec2bc-cf12-b513-e063-6394a90a94472026-06-30WarningsExact identifier
application number: M001
Childrens Stomach ReliefCALCIUM CARBONATEChain Drug Marketing Association, Inc.fb47d693-72d7-4586-9855-5e833ad1406f2026-06-18WarningsExact identifier
application number: M001
Dr. Sana Alivio Digestivo UPSET STOMACHEFEFERVESCENT ANTACIDEVI LABS51b8750c-3fcf-2543-e063-6394a90a7a8f2026-06-16WarningsExact identifier
application number: M001
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
application number: M001
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
application number: M001
Maximum Strength Calcium Carbonate 1000mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24ce4597-b571-3cbf-e063-6394a90a8ea22026-06-09WarningsExact identifier
application number: M001
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact 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