FDA.reportPublic FDA data

Rolaids ULTRA STRENGTH 1200

Product NDC
84126-325
11-digit product format
841260325
Labeler code
84126
Product ID
84126-325_5cdb5449-9fb7-3f76-e063-6394a90a065c
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
2024-12-09
Substance
CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength
1000; 200 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], 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 ULTRA STRENGTH 1200
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
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
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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
84126-325-10Rolaids ULTRA STRENGTH 120010 in 1 PACKAGETABLET, CHEWABLE103
84126-325-72Rolaids ULTRA STRENGTH 120072 in 1 BOTTLE, PLASTICTABLET, CHEWABLE723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-325ROLAIDS ULTRA STRENGTH 1200 (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 2 package rows20241210_28d9897d-46bf-d206-e063-6394a90a2b27.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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids Ultra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.8806c912-ab83-4f45-ac78-e826bb3143d42026-01-14WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Wild BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.07649a83-0123-4bb5-b130-3067c7d052c52026-01-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e1a46c-5665-ac4c-e063-6294a90a9b812026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e19b30-3784-ad98-e063-6294a90aa5662026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEMedical Group Care LLC47e1bc32-baf5-ad9a-e063-6294a90ad5b42026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC47e1c7c7-4f3b-c04b-e063-6394a90a775f2026-01-08WarningsExact identifier
application number: M001
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
application number: M001
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
application number: M001
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
application number: M001
QC Ultra Strength Antacid Soft Chews, CherryQC ANTACID SOFT CHEWS, CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a97517-d3e7-d896-e063-6394a90acc952025-12-29WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATESelect Consumer Group3caa037e-3424-f9ce-e063-6294a90ac1e82025-12-27WarningsExact identifier
application number: M001
AntacidANTACIDXiamen Kang Zhongyuan Biotechnology Co., Ltd.17adb983-bb28-bf8b-e063-6394a90a7daa2025-12-26WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438105calcium carbonate 1000 MG / magnesium hydroxide 200 MG Chewable TabletPSN28d9897d-46bf-d206-e063-6394a90a2b273
1438107Rolaids ULTRA 1000 MG / 200 MG Chewable Tablet, Reformulated Aug 2006PSN28d9897d-46bf-d206-e063-6394a90a2b273
1438107calcium carbonate 1000 MG / magnesium hydroxide 200 MG Chewable Tablet [Rolaids Reformulated Aug 2006]SBD28d9897d-46bf-d206-e063-6394a90a2b273
1438105calcium carbonate 1000 MG / magnesium hydroxide 200 MG Chewable TabletSCD28d9897d-46bf-d206-e063-6394a90a2b273
1438107Rolaids Ultra (calcium carbonate 1000 MG / magnesium hydroxide 200 MG) Chewable Tablet, Reformulated Aug 2006SY28d9897d-46bf-d206-e063-6394a90a2b273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-325-108412603251010 TABLET, CHEWABLE in 1 PACKAGE (84126-325-10) 2024-12-09NoNoCurrent
84126-325-728412603257272 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (84126-325-72) 2024-12-09NoNoCurrent