FDA.reportPublic FDA data

Rolaids

Product NDC
84126-347
Requested package NDC
84126-347-32
11-digit product format
841260347
Labeler code
84126
Product ID
84126-347_5cdaea95-e9d4-da53-e063-6394a90a8a9a
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-04
Substance
CALCIUM CARBONATE
Active strength
1000 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
Brand name suffix
POWER CHEWS 1000
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1000 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-347-32RolaidsPOWER CHEWS 100032 in 1 BOTTLE, PLASTICTABLET, CHEWABLE321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-347ROLAIDS POWER CHEWS 1000 (CALCIUM CARBONATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20250309_2f9ea017-a48d-a225-e063-6294a90a9ec3.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 31 of 34 · 667 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
application number: M001
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
application number: M001
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
application number: M001
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
application number: M001
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
application number: M001
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
application number: M001
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
application number: M001
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN2f9ea017-a48d-a225-e063-6294a90a9ec31
308892calcium carbonate 1000 MG Chewable TabletSCD2f9ea017-a48d-a225-e063-6294a90a9ec31
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY2f9ea017-a48d-a225-e063-6294a90a9ec31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-347-328412603473232 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (84126-347-32) 2025-03-04NoNoCurrent