FDA.reportPublic FDA data

calcium antacidextra strength

Product NDC
0536-1049
11-digit product format
005361049
Labeler code
0536
Product ID
0536-1049_450c9f27-9f92-16a2-e063-6394a90a829c
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rugby Laboratories
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-15
Substance
CALCIUM CARBONATE
Active strength
750 mg/1
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0536-1049-228af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0536-1049-22834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0536-1049-221332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0536-1049-22fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0536-1049-2286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0536-1049-22bd6a592717d7…303034d00443…

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
calcium antacidextra strength
Brand name suffix
extra strength
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308915Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d761954f-940e-4833-87b7-173a921aade1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1049-222024-07-04C16284748780-1d6a99b39-66d4-a426-e053-dadaa90af4c2Rugby. Calcium Antacid Tablets Drug Facts
0536-1049-222022-01-28C16284748780-1d6a99b39-66d4-a426-e053-dadaa90af4c2Rugby. Calcium Antacid Tablets Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1049-22calcium antacidextra strengthextra strength96 in 1 BOTTLETABLET, CHEWABLE965

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1049-22EA - Each0536-10496ebfb9dd-a626-4fa1-82ff-ac372c4130c012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGKCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7DCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1049CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 1 package rows20240705_d761954f-940e-4833-87b7-173a921aade1.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 4 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLCef9ecb48-b394-4a85-8ba8-aa397d20cd842026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLC49bd9752-ddfd-4cb1-bef6-22b4e5b95a372026-08-07WarningsExact identifier
application number: M001
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC1858cf76-cf36-4c56-9e15-14db609aa10f2026-08-07WarningsExact identifier
application number: M001
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLCe325d899-d9a6-5adb-e053-2995a90ac8612026-08-04WarningsExact identifier
application number: M001
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
application number: M001
Extra Strength Assorted BerryCALCIUM CARBONATEBJWCbc56a82e-b875-4a4c-9b49-4bfbc69187242026-07-22WarningsExact identifier
application number: M001
Best Choice Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)BEST CHOICE (VALU MERCHANDISERS COMPANY)1547b549-efd0-46da-8f91-3d7e4d4a2f3a2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Berry FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDE,SIMETHICONEBEST CHOICE (VALU MERCHANDISERS COMPANY)529d7da6-5997-41f5-bfb8-33d2bbdce78e2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Tropical FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)09e25e8e-a861-45cb-a919-36c30d3b7f7b2026-07-17WarningsExact identifier
application number: M001
LEADER ULTRA STRENGTHANTACID CALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER713c74bf-f586-4c63-82aa-5ed3a611d7a02026-07-17WarningsExact identifier
application number: M001
Best Choice Regular StrengthCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)a05bc8e7-ffc1-4abb-ade5-c3394a7e49bd2026-07-17WarningsExact identifier
application number: M001
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthCALCIUM CARBONATE ,MAGNESIUM HYDROXIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)1989551d-b977-4d5e-8b01-153cd9d638fc2026-07-17WarningsExact identifier
application number: M001
Best Choice Extra Strength Assorted BerryCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)412a5be3-2f90-483c-8169-b733861f3aa12026-07-17WarningsExact identifier
application number: M001
Best Choice Assorted FruitCALCIUM CARBONATEBEST CHOICE (VALU MERCHANDISERS COMPANY)cd9e2e11-25a8-4096-870a-9d0269e6c7a92026-07-17WarningsExact identifier
application number: M001
Best Choice Extra StrengthSMOOTH ANTACID TABLETSBEST CHOICE (VALU MERCHANDISERS COMPANY)c5141eb9-d851-453e-b51c-f436a647495a2026-07-17WarningsExact identifier
application number: M001
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
application number: M001
SimethiconeTARGET BERRY BLAST ANTACID HBG CHEWTarget5245af45-77c7-c95f-e063-6294a90a24f72026-07-15WarningsExact identifier
application number: M001
Amazon Basics Cherry Antacid SCCALCIUM CARBONATEAmazon4b1d6e4e-8b59-ec06-e063-6394a90aa60d2026-07-15WarningsExact identifier
application number: M001
FEVIA Acid ControlCALCIUM CARBONATEVIVUNT PHARMA LLC4b1bd2d1-c909-f5db-e063-6394a90a84bc2026-07-15WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308915calcium carbonate 750 MG (Ca 300 MG) Chewable TabletPSNd761954f-940e-4833-87b7-173a921aade15
308915calcium carbonate 750 MG Chewable TabletSCDd761954f-940e-4833-87b7-173a921aade15
308915calcium carbonate 750 MG (calcium 300 MG) Chewable TabletSYd761954f-940e-4833-87b7-173a921aade15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1049-220053610492296 TABLET, CHEWABLE in 1 BOTTLE (0536-1049-22) 2015-03-150000-00-00NoNoCurrent