FDA.reportPublic FDA data

TUMS

Product NDC
0135-0074
11-digit product format
001350074
Labeler code
0135
Product ID
0135-0074_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

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 Identifiers#

Field, Values table
FieldValues
UniiH0G9379FGK
Rxcui308915, 1044532

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0074-012020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-062020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-072020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-222020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-242020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-252020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-462020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-472020-02-28C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-012020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-062020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-072020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-222020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-242020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-252020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-462020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts
0135-0074-472020-01-31C16284748780-19d75b9d0-c406-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0074-01TUMSEX116 in 1 BOTTLETABLET11618
0135-0074-06TUMSEX70 in 1 BOTTLETABLET7018
0135-0074-07TUMSEX330 in 1 BOTTLETABLET33018
0135-0074-09TUMSEX170 in 1 BOTTLETABLET17018
0135-0074-22TUMSEX48 in 1 BOTTLETABLET4818
0135-0074-24TUMSEX8 in 1 PACKAGETABLET818
0135-0074-24TUMSEX3 in 1 CELLO PACKTABLET318
0135-0074-25TUMSEX96 in 1 BOTTLETABLET9618
0135-0074-46TUMSEX8 in 1 PACKAGETABLET818
0135-0074-47TUMSEX3 in 1 PACKAGETABLET318
0135-0074-47TUMSEX96 in 1 BOTTLETABLET9618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0074-01EA - Each0135-0074cb8b7b11-d67c-4b66-be62-e9082eadc88612017-11-06
0135-0074-06EA - Each0135-0074266b61c0-94fa-49ce-8092-3d59b0bc8e8412025-06-13
0135-0074-07EA - Each0135-0074861ce931-23c7-4d2e-b4a7-9d18e5310b5a12012-07-24
0135-0074-22EA - Each0135-0074adb9ed9e-59de-4b73-9879-73367ff6395012012-07-24
0135-0074-24EA - Each0135-0074b532bf99-1024-4de3-89e8-695a65bdb57712012-07-24
0135-0074-25EA - Each0135-007489d04672-7008-4868-9780-97de316b300a12012-07-24
0135-0074-46EA - Each0135-0074b994f71c-a340-4325-b8d8-ae693de93e2412012-07-24

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
0135-0074TUMS EX (CALCIUM CARBONATE) TABLET [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 11 package rows20241207_593a0494-d669-4bcf-8412-b92645b2d76c.zip

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
0135-0074-0100135007401116 TABLET in 1 BOTTLE (0135-0074-01) 116 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-060013500740670 TABLET in 1 BOTTLE (0135-0074-06) 70 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-0700135007407330 TABLET in 1 BOTTLE (0135-0074-07) 330 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-0900135007409170 TABLET in 1 BOTTLE (0135-0074-09) 170 tablet2024-06-10NoNoHistorical
0135-0074-220013500742248 TABLET in 1 BOTTLE (0135-0074-22) 48 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-24001350074243 PACKAGE in 1 CELLO PACK (0135-0074-24) / 8 TABLET in 1 PACKAGE3 package2010-01-180000-00-00NoNoCurrent
0135-0074-250013500742596 TABLET in 1 BOTTLE (0135-0074-25) 96 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-46001350074468 TABLET in 1 PACKAGE (0135-0074-46) 8 tablet2010-01-180000-00-00NoNoCurrent
0135-0074-47001350074473 BOTTLE in 1 PACKAGE (0135-0074-47) / 96 TABLET in 1 BOTTLE3 bottle2017-10-150000-00-00NoNoCurrent