FDA.reportPublic FDA data

TUMS

Product NDC
0135-0178
11-digit product format
001350178
Labeler code
0135
Product ID
0135-0178_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

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 packagepackage0135-01780135-0178-01DDiscontinued by firm2026-10-15

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
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
0135-0178-012020-02-28Drug Facts
0135-0178-022020-02-28Drug Facts
0135-0178-032020-02-28Drug Facts
0135-0178-052020-02-28Drug Facts
0135-0178-082020-02-28Drug Facts
0135-0178-092020-02-28Drug Facts
0135-0178-012020-01-31Drug Facts
0135-0178-022020-01-31Drug Facts
0135-0178-032020-01-31Drug Facts
0135-0178-052020-01-31Drug Facts
0135-0178-082020-01-31Drug Facts
0135-0178-092020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0178-01TUMSEX116 in 1 BOTTLETABLET11618
0135-0178-02TUMSEX48 in 1 BOTTLETABLET4818
0135-0178-03TUMSEX96 in 1 BOTTLETABLET9618
0135-0178-05TUMSEX70 in 1 BOTTLETABLET7018
0135-0178-08TUMSEX8 in 1 PACKAGETABLET818
0135-0178-09TUMSEX200 in 1 BOTTLETABLET20018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0178-02EA - Each0135-0178aa0dead0-393e-4f86-a678-29842845c6b112012-07-24
0135-0178-03EA - Each0135-0178828a68d4-668d-42ed-bba1-f340b3d73b4e12012-07-24
0135-0178-08EA - Each0135-01781c31cdb9-111a-460f-add0-c55b1f997c4512012-07-24
0135-0178-09EA - Each0135-01784338679f-0c13-4bd5-9293-15b0e28be12d12017-04-05

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
0135-0178TUMS EX (CALCIUM CARBONATE) TABLET [HALEON US HOLDINGS LLC]18Current NDC, Legacy NDC, 6 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 32 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
application number: M001
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
application number: M001
GERI-LANTA SUPREME CHERRYCALCIUM CARBONATE, MAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp7fbc654b-a0d4-408c-bb5a-eb50b7b543822023-11-08WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact 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
0135-0178-0100135017801116 in 1 BOTTLEHistorical
0135-0178-020013501780248 TABLET in 1 BOTTLE (0135-0178-02) 48 tablet2010-01-180000-00-00NoNoCurrent
0135-0178-030013501780396 TABLET in 1 BOTTLE (0135-0178-03) 96 tablet2010-01-180000-00-00NoNoCurrent
0135-0178-050013501780570 TABLET in 1 BOTTLE (0135-0178-05) 70 tablet2010-01-180000-00-00NoNoCurrent
0135-0178-08001350178088 TABLET in 1 PACKAGE (0135-0178-08) 8 tablet2010-01-180000-00-00NoNoCurrent
0135-0178-0900135017809200 TABLET in 1 BOTTLE (0135-0178-09) 200 tablet2010-01-180000-00-00NoNoCurrent