FDA.reportPublic FDA data

Calcium Antacid

Product NDC
69168-219
11-digit product format
691680219
Labeler code
69168
Product ID
69168-219_66ec4640-13ef-4811-a9ed-5fca3b67ffa3
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Allegiant Health
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-16
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69168-21969168-219-50DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Calcium 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
551d6135-2650-4c27-a20d-d56a9aba7b71Available 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, Related label table
NDCEffectiveRelated label
69168-219-022020-03-13Drug Facts
69168-219-502020-03-13Drug Facts
69168-219-022020-01-31Drug Facts
69168-219-502020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-219-02Calcium Antacid150 in 1 BOTTLETABLET, CHEWABLE15010
69168-219-50Calcium Antacid50 in 1 BOTTLETABLET, CHEWABLE5010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]2
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-219CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]9Current NDC, Legacy NDC, 2 package rows20231114_551d6135-2650-4c27-a20d-d56a9aba7b71.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 25 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
application number: M001
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
application number: M001
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
application number: M001
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
application number: M001
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEH E B19a3221f-e0c1-c47a-e063-6394a90a1f012025-01-14WarningsExact identifier
application number: M001
Childrens Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Aphena Pharma Solutions - Tennessee, LLCac839363-94fd-4c60-b5b6-70e4488ce1dd2025-01-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN551d6135-2650-4c27-a20d-d56a9aba7b7110
308907calcium carbonate 500 MG Chewable TabletSCD551d6135-2650-4c27-a20d-d56a9aba7b7110
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY551d6135-2650-4c27-a20d-d56a9aba7b7110
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN636a00a9-9df5-40cb-940a-61cc52016a1b3
308907calcium carbonate 500 MG Chewable TabletSCD636a00a9-9df5-40cb-940a-61cc52016a1b3
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY636a00a9-9df5-40cb-940a-61cc52016a1b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69168-219-0269168021902150 TABLET, CHEWABLE in 1 BOTTLE (69168-219-02) 2023-05-010000-00-00NoNoCurrent
69168-219-506916802195050 TABLET, CHEWABLE in 1 BOTTLE (69168-219-50) 2014-12-160000-00-00NoNoCurrent