FDA.reportPublic FDA data

Alkums antacid

Product NDC
53041-126
11-digit product format
530410126
Labeler code
53041
Product ID
53041-126_f8834ce9-ce9f-4e00-abf4-d9a1f6e7e84d
Type
HUMAN OTC DRUG
Nonproprietary name
calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Guardian Drug Company
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-01
Substance
CALCIUM CARBONATE
Active strength
500 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alkums antacid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui210111, 308907

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53041-126-172025-02-06C16284748780-1d6a99b39-8621-a426-e053-dadaa90af4c2Alkums Regular strength Antacid Assorted Fruit Tablets
53041-126-172022-01-28C16284748780-1d6a99b39-8621-a426-e053-dadaa90af4c2Alkums Regular strength Antacid Assorted Fruit Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-126-17Alkums antacid150 in 1 BOTTLETABLET, CHEWABLE1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-126ALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]3Current NDC, Legacy NDC, 1 package rows20250209_7451cd9f-1723-46d0-837e-8dc48bfb6bba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210111Alkums 500 MG Chewable TabletPSN7451cd9f-1723-46d0-837e-8dc48bfb6bba3
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN7451cd9f-1723-46d0-837e-8dc48bfb6bba3
210111calcium carbonate 500 MG Chewable Tablet [Alkums]SBD7451cd9f-1723-46d0-837e-8dc48bfb6bba3
308907calcium carbonate 500 MG Chewable TabletSCD7451cd9f-1723-46d0-837e-8dc48bfb6bba3
210111Alkums 500 MG (calcium 200 MG) Chewable TabletSY7451cd9f-1723-46d0-837e-8dc48bfb6bba3
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY7451cd9f-1723-46d0-837e-8dc48bfb6bba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53041-126-1753041012617150 TABLET, CHEWABLE in 1 BOTTLE (53041-126-17) 2012-02-010000-00-00NoNoCurrent