FDA.reportPublic FDA data

Extra Strength

Product NDC
51316-021
11-digit product format
513160021
Labeler code
51316
Product ID
51316-021_606c0eb9-92ee-407a-9a9f-4d06f9b39e21
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CVS PHARMACY
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-02
Substance
CALCIUM CARBONATE
Active strength
750 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
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
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE750 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
308915Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3cd6627-cd82-4d39-9593-55f016c72eecAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-021-96Extra Strength96 in 1 BOTTLETABLET, CHEWABLE965

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-021EXTRA STRENGTH (ANTACID TABLETS) TABLET, CHEWABLE [CVS PHARMACY]4Current NDC, Legacy NDC, 1 package rows20240817_f3cd6627-cd82-4d39-9593-55f016c72eec.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 17 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Antacid Calcium Carbonate,750 mgCALCIUM CARBONATETARGET CORPORATION07aa39bb-c409-ce4f-e063-6394a90a70692025-11-04WarningsExact identifier
application number: M001
ADVANCED REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY5faf6229-b0fd-58df-e053-2a91aa0ab3bb2025-10-30WarningsExact identifier
application number: M001
Regular Strength AntacidCALCIUM CARBONATESAFEWAYce44254f-6e33-4cbd-a609-6a926376efaf2025-10-29WarningsExact identifier
application number: M001
Extra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS, LLC9b311b76-1892-4b74-a07a-8b321436d4a02025-10-29WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSSAFEWAYf91aa7da-8bdc-4fd2-a9de-fef21674e5152025-10-29WarningsExact identifier
application number: M001
Extra Strength SmoothCALCIUM CARBONATESAFEWAY4314ac58-03aa-479c-a711-4818cc3325312025-10-29WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSSAFEWAY5bdb868d-016d-4175-9283-86c5b77bb26e2025-10-29WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSSAFEWAY03853f03-081d-4a78-b383-66ac9754d46f2025-10-29WarningsExact identifier
application number: M001
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC3ff92c9a-987f-468e-9e18-1e3e171ede142025-10-29WarningsExact identifier
application number: M001
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC35b3d9d0-b04d-4f6d-b99d-435233803d4b2025-10-29WarningsExact identifier
application number: M001
Ultra StrengthANTACID TABLETSSAFEWAY4c6cdd81-5145-4a1f-888f-85cf5d856c392025-10-29WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSSAFEWAY8ed35c3b-9878-4889-90f7-a3973cf806e02025-10-29WarningsExact identifier
application number: M001
Publix Regular Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCfd637431-7a08-4454-9cae-a68716d2d0fa2025-10-28WarningsExact identifier
application number: M001
Publix Regular Strength Peppermint FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCc41b6cc2-c852-45fd-858c-c7bedc5dc8822025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Assorted BerryCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCa270fc36-f2b2-4f56-81d4-cf165f6b5abe2025-10-28WarningsExact identifier
application number: M001
Extra Strength Sugar Free Orange Cream FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC4dbdabc4-280d-4c9a-8c54-84afc615c8c72025-10-28WarningsExact identifier
application number: M001
Publix Extra Strength Tropical FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC28e8dd03-25cf-43db-8c4d-3aae99be9d532025-10-28WarningsExact identifier
application number: M001
Publix Ultra Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC9e1c883f-016e-4c05-b27a-750d14c0f3e52025-10-28WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATEWal-Mart Stores,Inc.,48827658-02f7-4599-a90a-1543b30b9de12025-10-27WarningsExact identifier
application number: M001
Regular Strength AntacidANTACIDWal-Mart Stores,Inc.,6e7cd170-b169-4fc0-bc90-f4421bbd9fcd2025-10-27WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSNf3cd6627-cd82-4d39-9593-55f016c72eec5
308915calcium carbonate 750 MG Chewable TabletSCDf3cd6627-cd82-4d39-9593-55f016c72eec5
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSYf3cd6627-cd82-4d39-9593-55f016c72eec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-021-965131600219696 TABLET, CHEWABLE in 1 BOTTLE (51316-021-96) 2021-08-020000-00-00NoNoCurrent