FDA.reportPublic FDA data

TUMS

Product NDC
0135-0246
11-digit product format
001350246
Labeler code
0135
Product ID
0135-0246_4e6d1e5b-2025-907d-e063-6294a90abe8c
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
2010-03-24
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
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 · 6 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage0135-0246-07
excluded packagepackage0135-0246-05
excluded packagepackage0135-0246-02
excluded packagepackage0135-0246-01
excluded packagepackage0135-0246-04

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
Smoothies
Listing expiration
2027-12-31

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
c22944b8-8733-4689-be0c-f320467f79eaAvailable 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0246-012023-02-17Drug Facts
0135-0246-022023-02-17Drug Facts
0135-0246-042023-02-17Drug Facts
0135-0246-052023-02-17Drug Facts
0135-0246-072023-02-17Drug Facts
0135-0246-012022-07-29Drug Facts
0135-0246-022022-07-29Drug Facts
0135-0246-042022-07-29Drug Facts
0135-0246-052022-07-29Drug Facts
0135-0246-072022-07-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0246-01TUMSSmoothies12 in 1 CELLO PACKTABLET, CHEWABLE1221
0135-0246-02TUMSSmoothies60 in 1 BOTTLETABLET, CHEWABLE6021
0135-0246-04TUMSSmoothies72 in 1 BOTTLETABLET, CHEWABLE7221
0135-0246-05TUMSSmoothies140 in 1 BOTTLETABLET, CHEWABLE14021
0135-0246-07TUMSSmoothies250 in 1 BOTTLETABLET, CHEWABLE25021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0246-01EA - Each0135-02465df3290b-bb27-4cf8-8c86-9f263280492912016-09-02
0135-0246-02EA - Each0135-0246c7ecf7e3-0cbe-4c74-82a8-1255abe39cc412012-07-24
0135-0246-05EA - Each0135-02460d587724-8816-4b35-b318-9c01d518367512025-05-14
0135-0246-07EA - Each0135-0246f1522a31-bec4-48e3-9df0-ead5213d27e312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
GUAR GUMINACTIVE INGREDIENTE89I1637KETUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
SORBITOLINACTIVE INGREDIENT506T60A25RTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10
SUCROSEINACTIVE INGREDIENTC151H8M554TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEATHCARE LP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0246TUMS SMOOTHIES (CALCIUM CARBONATE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 5 package rows20250228_c22944b8-8733-4689-be0c-f320467f79ea.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 31 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUMS CHEWY BITESCALCIUM CARBONATE TABLET, CHEWABLELil' Drug Store Products, Inc.f67bd767-e9f1-2377-e053-2a95a90a0a2d2024-03-29WarningsExact identifier
application number: M001
Childrens Robitussin Cough and Cold CFDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCfcd0a8e0-ac2a-039a-be3c-534195d6bcfd2024-03-17WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC35f79dcf-1743-4d9f-aba5-5ead6b0563092024-03-15WarningsExact identifier
application number: M001
TUMS extra strength, smoothiesCALCIUM CARBONATEHaleon US Holdings LLC11078d7c-373b-4c7b-b33b-f1deba613fc12024-03-14WarningsExact identifier
application number: M001
Tums Chewy Bites Tropical Fruit SmoothieCALCIUM CARBONATEHaleon US Holdings LLC500f821e-dd27-4c7c-b629-a826b2e57c132024-03-11WarningsExact identifier
application number: M001
TUMSCALCIUM CARBONATEHaleon US Holdings LLC3988e3f8-b276-43a0-bdd3-01ddd422c9862024-03-03WarningsExact identifier
application number: M001
TUMS SmoothiesCALCIUM CARBONATEHaleon US Holdings LLC9e54f687-4072-42fd-a14b-af67fe8b6cc42024-03-03WarningsExact identifier
application number: M001
Tums Regular StrengthCALCIUM CARBONATEHaleon US Holdings LLCac80f627-3f51-425b-8c75-e07363048b002024-03-03WarningsExact identifier
application number: M001
Tums Chewy Bites Mixed FruitCALCIUM CARBONATEHaleon US Holdings LLCd341b832-edcf-4cb2-96e1-c303b030c59a2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC5090f60f-fa98-470b-bafd-bb64e6b28fcc2024-03-02WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATEHaleon US Holdings LLC453ceee1-414b-4f4c-8408-eb540a79ca052024-03-02WarningsExact identifier
application number: M001
Tums Chewy Bites Berry ShakeCALCIUM CARBONATEHaleon US Holdings LLC9043983c-7ee4-4971-8885-36f814bb570f2024-03-02WarningsExact identifier
application number: M001
Tums Chewy DelightsCALCIUM CARBONATEHaleon US Holdings LLC189850d0-6f06-45bd-bd7e-9063ee580d0b2024-03-02WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfe04c244-d9b8-2800-e053-6294a90aeedc2024-02-06WarningsExact identifier
application number: M001
Mylanta ClassicCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a4cf29-39ed-87c3-e063-6394a90a49732024-02-05WarningsExact identifier
application number: M001
Mylanta Vanilla CaramelCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEInfirst Healthcare Inc.10a66d74-74b4-3f8d-e063-6394a90a7f002024-02-05WarningsExact identifier
application number: M001
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
application number: M001
Mylanta Coat and CoolCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEINFIRST HEALTHCARE INC.b6571f7f-e1ea-4034-a46c-4de1d01beec32024-01-01WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSNc22944b8-8733-4689-be0c-f320467f79ea21
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSNc22944b8-8733-4689-be0c-f320467f79ea21
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBDc22944b8-8733-4689-be0c-f320467f79ea21
308915calcium carbonate 750 MG Chewable TabletSCDc22944b8-8733-4689-be0c-f320467f79ea21
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSYc22944b8-8733-4689-be0c-f320467f79ea21
1044532Tums Chewy Bites 750 MG Chewable TabletSYc22944b8-8733-4689-be0c-f320467f79ea21
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSYc22944b8-8733-4689-be0c-f320467f79ea21
1044532Tums Kids 750 MG Chewable TabletSYc22944b8-8733-4689-be0c-f320467f79ea21
1044532Tums Smoothies 750 MG Chewable TabletSYc22944b8-8733-4689-be0c-f320467f79ea21
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSN1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532Tums Extra Strength 750 MG (Ca 300 MG) Chewable TabletPSN1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532calcium carbonate 750 MG Chewable Tablet [Tums]SBD1d544441-ff1d-64f4-e063-6294a90a8fc81
308915calcium carbonate 750 MG Chewable TabletSCD1d544441-ff1d-64f4-e063-6294a90a8fc81
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSY1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532Tums Chewy Bites 750 MG Chewable TabletSY1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532Tums E-X 750 MG (calcium 300 MG) Chewable TabletSY1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532Tums Kids 750 MG Chewable TabletSY1d544441-ff1d-64f4-e063-6294a90a8fc81
1044532Tums Smoothies 750 MG Chewable TabletSY1d544441-ff1d-64f4-e063-6294a90a8fc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0135-0246-010013502460112 TABLET, CHEWABLE in 1 CELLO PACK (0135-0246-01) 2010-03-240000-00-00NoNoCurrent
0135-0246-020013502460260 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-02) 2010-03-240000-00-00NoNoCurrent
0135-0246-040013502460472 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-04) 2017-03-140000-00-00NoNoCurrent
0135-0246-0500135024605140 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-05) 2014-08-100000-00-00NoNoCurrent
0135-0246-0700135024607250 TABLET, CHEWABLE in 1 BOTTLE (0135-0246-07) 2016-01-260000-00-00NoNoCurrent