FDA.reportPublic FDA data

TUMS

Product NDC
0135-0540
11-digit product format
001350540
Labeler code
0135
Product ID
0135-0540_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

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
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct0135-0540IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0135-05400135-0540-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…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#

Effective, Related label table
EffectiveRelated label
2020-12-01Drug Facts
2020-12-01Drug Facts
2020-12-01Drug Facts
2020-01-31Drug Facts
2020-01-31Drug Facts
2020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0540-01TUMSULTRA86 in 1 BOTTLETABLET, CHEWABLE8619

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
0135-0540TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]19Current NDC, Legacy NDC, 1 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 5 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4d695a90-6502-3020-e063-6394a90ab0c32026-07-15WarningsExact identifier
application number: M001
GOOD NEIGHBOR PHARMACY Antacid Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEAmerisource Bergen5e346dc0-69ce-4cc5-bb5d-bfa833e11c1f2026-07-13WarningsExact identifier
application number: M001
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
application number: M001
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
application number: M001
Omeprazole, 24/7 Life by 7-ElevenOMEPRAZOLE TABLET, DELAYED RELEASELil' Drug Store Products, Inc.36d8a272-6cca-e759-e063-6394a90a9df82026-07-08WarningsExact identifier
application number: M001
Tums UltraCALCIUM CARBONATEHaleon US Holdings LLCc544120f-15f0-48b5-88b2-d4820f180f502026-07-07WarningsExact identifier
application number: M001
Regular Strength Assorted FlavorsANTACID CALCIUM CARBONATEAKRON PHARMA INC3f7fe022-aee9-b899-e063-6394a90afb4e2026-07-07WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEWestminster Pharmaceuticals, LLC52eeac0e-94bb-48c3-81dc-578e96406c012026-07-06WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEPNP Pharmaceuticals Inc.5103a317-5c4a-ec96-e063-6294a90aad7e2026-07-01WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATEDOLGENCORP, LLC4d6ebc7e-ef39-47e8-91e9-f38484329fa92026-06-30WarningsExact identifier
application number: M001
Ultra Strength AntacidCALCIUM CARBONATE CHEWABLE TABLETSCVS Pharmacy. Inc.24cec2bc-cf12-b513-e063-6394a90a94472026-06-30WarningsExact identifier
application number: M001
Childrens Stomach ReliefCALCIUM CARBONATEChain Drug Marketing Association, Inc.fb47d693-72d7-4586-9855-5e833ad1406f2026-06-18WarningsExact identifier
application number: M001
Dr. Sana Alivio Digestivo UPSET STOMACHEFEFERVESCENT ANTACIDEVI LABS51b8750c-3fcf-2543-e063-6394a90a7a8f2026-06-16WarningsExact identifier
application number: M001
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
application number: M001
Mag-Al PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONECardinal Health 107, LLC08df7403-9ee3-4a43-a151-c1a6ef7a75492026-06-10WarningsExact identifier
application number: M001
Childrens AntacidCALCIUM CARBONATERite Aid Corporationd09c2d99-9a1f-4eae-a048-ab6dbf74a7982026-06-09WarningsExact identifier
application number: M001
Maximum Strength Calcium Carbonate 1000mgCALCIUM CARBONATE CHEWABLE TABLETSCVS HEALTH CORP24ce4597-b571-3cbf-e063-6394a90a8ea22026-06-09WarningsExact identifier
application number: M001
Tums Chewy Bites with Gas ReliefCALCIUM CARBONATE AND SIMETHICONEHaleon US Holdings LLC6d7be7e4-4bff-4cfd-bbbe-df412ac9db102026-06-09WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATENCS HealthCare of KY, LLC dba Vangard Labsfde4ea0c-152b-4b79-a6d8-2b0dbd9107aa2026-06-04WarningsExact 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
0135-0540-010013505400186 TABLET, CHEWABLE in 1 BOTTLE (0135-0540-01) 2010-02-120000-00-00NoNoCurrent