FDA.reportPublic FDA data

Tums Chewy Bites

Product NDC
0135-5969
11-digit product format
001355969
Labeler code
0135
Product ID
0135-5969_5f0093fa-82a3-51e4-e063-6294a90a5a79
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
2025-06-01
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0135-5969DDiscontinued by firm2026-11-13
excluded packagepackage0135-59690135-5969-60DDiscontinued by firm2026-11-13

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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0135-5969DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0135-59690135-5969-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Chewy Bites
Brand name suffix
Strawberries and Cream
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
ed861325-bd69-42fe-b901-e15add028c7aAvailable on FDA.report

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 13 of 31 · 617 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antacid Ultra StrengthANTACIDWALGREEN CO.09ef90c3-1fc3-48be-8071-2fa387a461752025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.6d6cecdc-646b-4c7b-b325-9423c29c57fc2025-11-25WarningsExact identifier
application number: M001
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.e1b55f3a-c6d7-4374-acc7-134786a3765e2025-11-25WarningsExact identifier
application number: M001
ULTRA STRENGTH AntacidCALCIUM CARBONATEWALGREEN COa4dcf7b9-d2c3-45d3-9410-fc4d55052a3c2025-11-25WarningsExact identifier
application number: M001
FAST ACTING Heartburn ReliefALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEWALGREEN CO.48c14005-811a-4868-b33e-9348455048562025-11-25WarningsExact identifier
application number: M001
Walgreens Childrens Saline LaxativeMAGNESIUM HYDROXIDEWALGREEN CO.3813ed22-cf68-4c16-9b61-c398281200792025-11-25WarningsExact identifier
application number: M001
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
application number: M001
GERI-MOX ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp03358bc7-8819-4a05-bc13-27fbf486bd262025-11-20WarningsExact identifier
application number: M001
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCd41f0b26-5add-4045-9754-37d70d120d282025-11-20WarningsExact identifier
application number: M001
Tums Chewy Bites Vanilla and MintCALCIUM CARBONATEHaleon US Holdings LLC2b9dd909-c850-3c21-e063-6394a90a15a82025-11-19WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd8fdf4-f762-f936-e053-2a91aa0aa6ee2025-11-19WarningsExact identifier
application number: M001
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5e996df3-25a4-b259-e053-2a91aa0a43112025-11-19WarningsExact identifier
application number: M001
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corpa7d7298f-44d6-4e09-8578-7fe3112430022025-11-19WarningsExact identifier
application number: M001
GERI-MOX MAX CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp8e57bcf5-2960-4c41-8bf2-83cb1ee501682025-11-19WarningsExact identifier
application number: M001
Tums Antacid Chewy BitesCALCIUM CARBONATE 750 MGR J General Corporation6208d11d-0670-4a20-a3fc-ebc764a8e6cd2025-11-17WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID/ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONERUGBY LABORATORIESb244fce9-9626-e947-e053-2995a90ab8f92025-11-17WarningsExact identifier
application number: M001
Antacid ChildrensCALCIUM CARBONATECVS Pharmacy08953df1-cc29-452f-bc69-b19970a1fd2e2025-11-15WarningsExact identifier
application number: M001
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID MINTALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS3ce054f3-2953-5f7d-e054-00144ff8d46c2025-11-11WarningsExact identifier
application number: M001
Topcare Antacid Extra Strength Assorted BerryCALCIUM CARBONATETopco Associates LLC14f6f475-32d6-4783-8dcc-1fe265902d552025-11-10WarningsExact identifier
application number: M001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-5969-60001355969601 BOTTLE in 1 CARTON (0135-5969-60) / 60 TABLET, CHEWABLE in 1 BOTTLE1 bottle2025-06-01NoNoCurrent