FDA.reportPublic FDA data

TUMS

Product NDC
0135-0228
11-digit product format
001350228
Labeler code
0135
Product ID
0135-0228_5ca009f2-85d1-1387-e063-6294a90ac707
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
2010-02-12
Substance
CALCIUM CARBONATE
Active strength
1000 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage0135-02280135-0228-07DDiscontinued by firm2026-10-16

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 · 17 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-0228-07DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0135-0228-07DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0135-0228-07DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0135-0228-07DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0135-0228-07DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0135-0228-07DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0135-0228-07DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0135-0228-07DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0135-0228-07DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0135-0228-07DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0135-0228-07DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0135-0228-07DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-0228-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-0228-05IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-0228-06IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-0228-04IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
ULTRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE1000 mg/1

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
0135-0228-012020-12-01Drug Facts
0135-0228-012020-12-01Drug Facts
0135-0228-012020-12-01Drug Facts
0135-0228-042020-12-01Drug Facts
0135-0228-042020-12-01Drug Facts
0135-0228-042020-12-01Drug Facts
0135-0228-052020-12-01Drug Facts
0135-0228-052020-12-01Drug Facts
0135-0228-052020-12-01Drug Facts
0135-0228-062020-12-01Drug Facts
0135-0228-062020-12-01Drug Facts
0135-0228-062020-12-01Drug Facts
0135-0228-072020-12-01Drug Facts
0135-0228-072020-12-01Drug Facts
0135-0228-072020-12-01Drug Facts
0135-0228-012020-01-31Drug Facts
0135-0228-012020-01-31Drug Facts
0135-0228-012020-01-31Drug Facts
0135-0228-042020-01-31Drug Facts
0135-0228-042020-01-31Drug Facts
0135-0228-042020-01-31Drug Facts
0135-0228-052020-01-31Drug Facts
0135-0228-052020-01-31Drug Facts
0135-0228-052020-01-31Drug Facts
0135-0228-062020-01-31Drug Facts
0135-0228-062020-01-31Drug Facts
0135-0228-062020-01-31Drug Facts
0135-0228-072020-01-31Drug Facts
0135-0228-072020-01-31Drug Facts
0135-0228-072020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0228-01TUMSULTRA12 in 1 PACKAGETABLET, CHEWABLE1219
0135-0228-04TUMSULTRA10 in 1 PACKAGETABLET, CHEWABLE1019
0135-0228-05TUMSULTRA160 in 1 BOTTLETABLET, CHEWABLE16019
0135-0228-06TUMSULTRA72 in 1 BOTTLETABLET, CHEWABLE7219
0135-0228-07TUMSULTRA86 in 1 BOTTLETABLET, CHEWABLE8619

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0228-01EA - Each0135-0228b819a5e3-083f-471a-b418-9ff6b34a7a9e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95LTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
SUCROSEINACTIVE INGREDIENTC151H8M554TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9
TALCINACTIVE INGREDIENT7SEV7J4R1UTUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0228TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 5 package rows20250524_f4786707-a0f7-4ba8-9656-06278d1b4b6c.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 25 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
application number: M001
Goodsense Ultra Strength AntacidCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)492deace-7ea1-4fe3-a4c7-b2c6f195d68c2025-01-20WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Ulai Health LLC641ae5b9-3bb6-41a1-ab12-367bf2fbcb0a2025-01-20WarningsExact identifier
application number: M001
GoodSense Extra Strength AntacidCALCIUM CARBONATEGoodSense2fcdeb06-17de-49d8-97bb-8d31e1c0c61f2025-01-20WarningsExact identifier
application number: M001
HEB Extra Stregth AntacidCALCIUM CARBONATEH E Bdcfe4c81-b6e0-4a9b-a521-f3ad0c0a8e482025-01-20WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEEverpharm LLC2bda74cb-e77d-46bb-e063-6394a90af5802025-01-16WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATECVS1bf90c0c-b639-1c06-e063-6394a90ab85b2025-01-16WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEReliable 1 Laboratories LLC321a772c-c44c-3d4e-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Calcium Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
application number: M001
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
application number: M001
Rolaids Extra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.604d79f3-cdfa-45e2-8c20-fa6e0ff09b2e2025-01-15WarningsExact identifier
application number: M001
Extra Strength Smooth AntacidCALCIUM CARBONATEH E B19a3221f-e0c1-c47a-e063-6394a90a1f012025-01-14WarningsExact identifier
application number: M001
Childrens Stomach Relief AntacidCALCIUM CARBONATEH E B18fae1aa-1001-8035-e063-6394a90adc662025-01-14WarningsExact identifier
application number: M001
Calcium Carbonate 10 gr (648 mg) (Antacid)CALCIUM CARBONATE 10GR (648 MG)Aphena Pharma Solutions - Tennessee, LLCac839363-94fd-4c60-b5b6-70e4488ce1dd2025-01-09WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSNf4786707-a0f7-4ba8-9656-06278d1b4b6c19
1044524Tums Ultra 1000 MG (Ca 400 MG) Chewable TabletPSNf4786707-a0f7-4ba8-9656-06278d1b4b6c19
1044524calcium carbonate 1000 MG Chewable Tablet [Tums]SBDf4786707-a0f7-4ba8-9656-06278d1b4b6c19
308892calcium carbonate 1000 MG Chewable TabletSCDf4786707-a0f7-4ba8-9656-06278d1b4b6c19
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSYf4786707-a0f7-4ba8-9656-06278d1b4b6c19
1044524Tums 1000 MG Chewable TabletSYf4786707-a0f7-4ba8-9656-06278d1b4b6c19
1044524Tums Ultra 1000 MG (calcium 400 MG) Chewable TabletSYf4786707-a0f7-4ba8-9656-06278d1b4b6c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0135-0228-010013502280112 TABLET, CHEWABLE in 1 PACKAGE (0135-0228-01) 2010-02-120000-00-00NoNoCurrent
0135-0228-040013502280410 TABLET, CHEWABLE in 1 PACKAGE (0135-0228-04) 2010-02-120000-00-00NoNoCurrent
0135-0228-0500135022805160 TABLET, CHEWABLE in 1 BOTTLE (0135-0228-05) 2010-02-120000-00-00NoNoCurrent
0135-0228-060013502280672 TABLET, CHEWABLE in 1 BOTTLE (0135-0228-06) 2010-02-120000-00-00NoNoCurrent
0135-0228-070013502280786 in 1 BOTTLEHistorical