Home NDC 69423-828 Rolaids Ultra Strength
Product NDC 69423-828
11-digit product format 694230828
Labeler code 69423
Product ID 69423-828_5cdb15a0-d2d7-4c3e-e063-6294a90a0219
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 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
Brand name suffix Mint
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 1000 mg/1 MAGNESIUM HYDROXIDE 200 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69423-828-10 Rolaids Ultra StrengthMint 10 in 1 PACKAGE TABLET, CHEWABLE 10 5 69423-828-72 Rolaids Ultra StrengthMint 72 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 72 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69423-828 ROLAIDS ULTRA STRENGTH MINT (CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 4 Current NDC, 2 package rows 20241019_0f8cfcc5-e975-6645-e063-6394a90adf6c.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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69423-828-10 69423082810 10 TABLET, CHEWABLE in 1 PACKAGE (69423-828-10) 2024-01-30 No No Current 69423-828-72 69423082872 72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69423-828-72) 2024-01-30 No No Current