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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53041-126-17302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53041-126-17ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53041-126-170efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53041-126-17ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53041-126-17367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53041-126-17557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53041-126-178af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53041-126-17834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53041-126-171332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53041-126-17fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53041-126-1786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53041-126-17bd6a592717d7…303034d00443…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H0G9379FGKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210111Internal RxNorm lookup
308907Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7451cd9f-1723-46d0-837e-8dc48bfb6bbaAvailable on FDA.report

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554ALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALKUMS ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]1

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

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 1 of 38 · 742 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
application number: M001
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
application number: M001
Best Choice Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)BEST CHOICE (VALU MERCHANDISERS COMPANY)1547b549-efd0-46da-8f91-3d7e4d4a2f3a2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Tropical FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)09e25e8e-a861-45cb-a919-36c30d3b7f7b2026-07-17WarningsExact identifier
application number: M001
LEADER ULTRA STRENGTHANTACID CALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER713c74bf-f586-4c63-82aa-5ed3a611d7a02026-07-17WarningsExact identifier
application number: M001
Best Choice Regular StrengthCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd2026-07-17WarningsExact identifier
application number: M001
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthCALCIUM CARBONATE ,MAGNESIUM HYDROXIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)1989551d-b977-4d5e-8b01-153cd9d638fc2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Assorted BerryCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)412a5be3-2f90-483c-8169-b733861f3aa12026-07-17WarningsExact identifier
application number: M001
Best Choice Assorted FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)cd9e2e11-25a8-4096-870a-9d0269e6c7a92026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthSMOOTH ANTACID TABLETSBEST CHOICE (VALU MERCHANDISERS COMPANY)c5141eb9-d851-453e-b51c-f436a647495a2026-07-17WarningsExact identifier
application number: M001
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpe62f6f6f-59a9-4df4-91ca-a76c4de93fe02026-07-15WarningsExact identifier
application number: M001
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
application number: M001
Amazon Basics Cherry Antacid SCCALCIUM CARBONATEAmazon4b1d6e4e-8b59-ec06-e063-6394a90aa60d2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001

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