FDA.reportPublic FDA data

Extra Strength Smooth

Product NDC
21130-515
11-digit product format
211300515
Labeler code
21130
Product ID
21130-515_4249d15f-ba26-9084-e063-6294a90a391b
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
SAFEWAY
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-05
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
2026-12-31
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 Smooth
Listing expiration
2026-12-31

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
4314ac58-03aa-479c-a711-4818cc332531Available 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
21130-515-60Extra Strength Smooth60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-515EXTRA STRENGTH SMOOTH (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFEWAY]5Current NDC, Legacy NDC, 1 package rows20241105_4314ac58-03aa-479c-a711-4818cc332531.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 2 of 36 · 719 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
application number: M001
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
application number: M001
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
application number: M001
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
application number: M001
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
application number: M001
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEPreferred Pharmaceuticals Inc.3b049027-30ac-4c78-a4f1-8191f7ed45bf2026-08-27WarningsExact identifier
application number: M001
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp534144be-fcaf-400d-b772-595c62ae6ea62026-08-27WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEGuardian Drug Company48ec50ab-f24b-367b-e063-6294a90ad7362026-08-27WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
application number: M001
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M001
Dr. Sana Lemon Alivio Digestivo UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59cdf417-e5c0-6bb2-e063-6294a90a9c512026-08-24WarningsExact identifier
application number: M001
Dr Sana Alivio Digestivo Naranja UPSET STOMACHEFFERVESCENT ANTACIDEVI LABS59d07c2d-ef11-bd32-e063-6394a90af87d2026-08-24WarningsExact identifier
application number: M001
Genexa Antacid Maximum StrengthCALCIUM CARBONATEGenexa Inc.3a39d91c-2dcd-71d6-e063-6394a90a54742026-08-22WarningsExact identifier
application number: M001
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
application number: M001
CVS Health Extra Strength AntacidALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY8629529e-4363-4d37-9ae0-27193868df322026-08-19WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
application number: M001
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
application number: M001
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN4314ac58-03aa-479c-a711-4818cc3325316
308915calcium carbonate 750 MG Chewable TabletSCD4314ac58-03aa-479c-a711-4818cc3325316
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY4314ac58-03aa-479c-a711-4818cc3325316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-515-602113005156060 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (21130-515-60) 2020-10-050000-00-00NoNoCurrent