Home NDC 70000-0459 LEADER Ultra Strength
Product NDC 70000-0459
11-digit product format 700000459
Labeler code 70000
Product ID 70000-0459_1ef40df3-78e7-4323-bfd2-e16abecce29c
Type HUMAN OTC DRUG
Nonproprietary name Chewable Antacid Tablets
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Cardinal Health
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-18
Substance CALCIUM CARBONATE
Active strength 1000 mg/1
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 LEADER Ultra Strength
Brand name suffix Peppermint Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308892 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0459-1 LEADER Ultra StrengthPeppermint Flavor 72 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 72 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0459 LEADER ULTRA STRENGTH PEPPERMINT FLAVOR (CHEWABLE ANTACID TABLETS) TABLET, CHEWABLE [CARDINAL HEALTH] 12 Current NDC, Legacy NDC, 1 package rows 20241122_3bf16b23-5a67-454f-b335-677cc49cd7a3.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 Marketing end Sample Exclude flag Status 70000-0459-1 70000045901 72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70000-0459-1) 2018-12-18 0000-00-00 No No Current