FDA.reportPublic FDA data

TUMS

Product NDC
0135-0227
11-digit product format
001350227
Labeler code
0135
Product ID
0135-0227_12c94278-9881-a2ff-e063-6394a90a8157
Type
HUMAN OTC DRUG
Nonproprietary name
calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-07
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

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct0135-0227IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0135-02270135-0227-01IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

Additional Listing Data#

Finished product
Yes
Brand name base
TUMS
Brand name suffix
Smoothies
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
9e54f687-4072-42fd-a14b-af67fe8b6cc4Available 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0227-012024-03-03C16284748780-1e4f33bdf-acd6-d8a0-e053-dadaa90a6e4eDrug Facts
0135-0227-012022-07-29C16284748780-1e4f33bdf-acd6-d8a0-e053-dadaa90a6e4eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0227-01TUMSSmoothies60 in 1 BOTTLETABLET, CHEWABLE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0227TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 1 package rows20240304_9e54f687-4072-42fd-a14b-af67fe8b6cc4.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 1 of 37 · 739 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CVS NaturalsCALCIUM CARBONATECVS PHARMACY899f057a-914d-49ca-a9fd-9fc48149782a2026-08-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Heartburn Relief Antacid Original FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.5c32d90b-68a0-4acf-94b6-d02037cea3762026-08-13WarningsExact identifier
application number: M001
Extra Strength SmoothANTACID TABLETSCVSc00204f7-c343-4451-9e0f-638ebb72f07c2026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY Extra Strength Cherry FlavorALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS Pharmacy,Inc.cf7ae053-fa8d-4e6e-af4f-b846699aaf242026-08-13WarningsExact identifier
application number: M001
CVS Extra Strength SmoothCALCIUM CARBONATECVS PHARMACY70752251-02fe-4639-a4a8-afef32463c322026-08-13WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted BerryANTACID TABLETSCVS PHARMACY,INC.19f0847e-1512-465c-b67f-d61ef4a16cfa2026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Berry AntacidCALCIUM CARBONATECVS7f0a4d88-4e3c-448e-90b1-ae03966b78062026-08-12WarningsExact identifier
application number: M001
Extra StrengthANTACID TABLETSCVS PHARMACYf3cd6627-cd82-4d39-9593-55f016c72eec2026-08-12WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar FreeANTACIDCVS PHARMACY, INC.49e23561-d392-415c-9e6f-2dbcf64c96362026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY Assorted Fruit AntacidCALCIUM CARBONATECVS8ab371eb-9839-47f0-b576-d917f69ed16d2026-08-12WarningsExact identifier
application number: M001
CVS Ultra StrengthANTACID TABLETSCVS6108271a-4336-4f90-9765-9c3aea1094882026-08-12WarningsExact identifier
application number: M001
CVS PHARMACY,INC. Assorted FruitANTACID TABLETSCVS PHARMACY,INC.60294e90-4b9c-4419-876c-3da037d76cfd2026-08-12WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.4cdf0cd0-f69f-4f86-a9ff-cda5cb002d652026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.ec3f0e47-52f3-4ffd-a3d3-71ef4bd11f082026-08-11WarningsExact identifier
application number: M001
Whole Foods Market Regular Strength Peppermint FlavorCALCIUM CARBONATEWHOLE FOODS MARKET, INC.639665ca-476e-4fbf-9378-a08cb28c15f62026-08-11WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD9e54f687-4072-42fd-a14b-af67fe8b6cc43
308915calcium carbonate 750 MG Chewable TabletSCD9e54f687-4072-42fd-a14b-af67fe8b6cc43
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532Tums Chewy Bites 750 MG Chewable TabletSY9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532Tums Kids 750 MG Chewable TabletSY9e54f687-4072-42fd-a14b-af67fe8b6cc43
1044532Tums Smoothies 750 MG Chewable TabletSY9e54f687-4072-42fd-a14b-af67fe8b6cc43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0135-0227-010013502270160 TABLET, CHEWABLE in 1 BOTTLE (0135-0227-01) 2019-10-070000-00-00NoNoCurrent