FDA.reportPublic FDA data

TUMS

Product NDC
0135-0076
11-digit product format
001350076
Labeler code
0135
Product ID
0135-0076_3ce3175f-47e7-4ea3-b5b6-836368fc7522
Type
HUMAN OTC DRUG
Nonproprietary name
calcium carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-18
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
TUMS
Brand name suffix
EX
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308915Internal RxNorm lookup
1044532Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
593a0494-d669-4bcf-8412-b92645b2d76cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0076-012020-02-28Drug Facts
0135-0076-252020-02-28Drug Facts
0135-0076-262020-02-28Drug Facts
0135-0076-012020-01-31Drug Facts
0135-0076-252020-01-31Drug Facts
0135-0076-262020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0076-01TUMSEX116 in 1 BOTTLETABLET11618
0135-0076-25TUMSEX96 in 1 BOTTLETABLET9618
0135-0076-26TUMSEX70 in 1 BOTTLETABLET7018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0076-25EA - Each0135-0076078c8418-953d-4359-81ae-bba9c1135e9c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
ACACIAINACTIVE INGREDIENT5C5403N26OTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1TUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
SORBITOLINACTIVE INGREDIENT506T60A25RTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
SUCROSEINACTIVE INGREDIENTC151H8M554TUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8
TALCINACTIVE INGREDIENT7SEV7J4R1UTUMS EX (CALCIUM CARBONATE) TABLET TUMS EX (CALCIUM CARBONATE) KIT [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0076TUMS EX (CALCIUM CARBONATE) TABLET [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 3 package rows20241207_593a0494-d669-4bcf-8412-b92645b2d76c.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 TabletPSN593a0494-d669-4bcf-8412-b92645b2d76c18
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN593a0494-d669-4bcf-8412-b92645b2d76c18
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD593a0494-d669-4bcf-8412-b92645b2d76c18
308915calcium carbonate 750 MG Chewable TabletSCD593a0494-d669-4bcf-8412-b92645b2d76c18
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY593a0494-d669-4bcf-8412-b92645b2d76c18
1044532Tums Chewy Bites 750 MG Chewable TabletSY593a0494-d669-4bcf-8412-b92645b2d76c18
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY593a0494-d669-4bcf-8412-b92645b2d76c18
1044532Tums Kids 750 MG Chewable TabletSY593a0494-d669-4bcf-8412-b92645b2d76c18
1044532Tums Smoothies 750 MG Chewable TabletSY593a0494-d669-4bcf-8412-b92645b2d76c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0076-0100135007601116 TABLET in 1 BOTTLE (0135-0076-01) 116 tablet2010-01-180000-00-00NoNoCurrent
0135-0076-250013500762596 TABLET in 1 BOTTLE (0135-0076-25) 96 tablet2010-01-180000-00-00NoNoCurrent
0135-0076-260013500762670 TABLET in 1 BOTTLE (0135-0076-26) 70 tablet2010-01-180000-00-00NoNoCurrent