FDA.reportPublic FDA data

Leader Extra Strength Sugar Free Antacid

Product NDC
70000-0460
11-digit product format
700000460
Labeler code
70000
Product ID
70000-0460_411c182e-9152-6b6f-e063-6394a90a4a86
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Cardinal Health
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-04
Substance
CALCIUM CARBONATE
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Extra Strength Sugar Free AntacidANTACIDCardinal Healthd7a6f1b8-bdf7-45bb-bab0-b22f45e784402025-10-14WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 9 tablets in 24 hours If pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Extra Strength Sugar Free Antacid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308915

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
70000-0460-1Leader Extra Strength Sugar Free Antacid90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0460-1EA - Each70000-046081eae8d1-5dd3-46e8-b75b-5b5935b3cbfd12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0460LEADER EXTRA STRENGTH SUGAR FREE ANTACID (ANTACID) TABLET, CHEWABLE [CARDINAL HEALTH]6Current NDC, Legacy NDC, 1 package rows20241122_d7a6f1b8-bdf7-45bb-bab0-b22f45e78440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSNd7a6f1b8-bdf7-45bb-bab0-b22f45e784407
308915calcium carbonate 750 MG Chewable TabletSCDd7a6f1b8-bdf7-45bb-bab0-b22f45e784407
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSYd7a6f1b8-bdf7-45bb-bab0-b22f45e784407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0460-17000004600190 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70000-0460-1) 2019-02-040000-00-00NoNoCurrent