FDA.reportPublic FDA data

Regular strength

Product NDC
68998-101
11-digit product format
689980101
Labeler code
68998
Product ID
68998-101_7be351b6-8a94-45fa-9b34-8d92962c2260
Type
HUMAN OTC DRUG
Nonproprietary name
Calcium Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
MARC GLASSMAN, INC.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-18
Substance
CALCIUM CARBONATE
Active strength
500 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

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
Regular strength
Brand name suffix
Assorted Fruit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68998-101-50Regular strengthAssorted Fruit150 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68998-101REGULAR STRENGTH ASSORTED FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [MARC GLASSMAN, INC.]7Current NDC, Legacy NDC, 1 package rows20241010_2a6be8a6-3221-4675-b41c-dd795a436fd5.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 26 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC59c16c09-c23d-4a37-8460-d6c00a268ed52024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
application number: M001
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.9119b7f0-3e8a-7be7-e053-2995a90a46342024-12-26WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.db5941b2-0a04-452a-8fbc-bd5e40fadfb12024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
application number: M001
Good Neighbor Pharmacy Antacid Extra StrengthCALCIUM CARBONATEAmerisourceBergen Drug Corporation5e3a3c20-dabe-4427-9e75-99759905caa02024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid Cherry liquidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC31d2e77d-5eda-4f47-917c-3390d6c782af2024-12-26WarningsExact identifier
application number: M001
Maximum Strength Antacid MintALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONETopco Associates, LLC50ceff1e-b6df-40f8-89f3-667cc8f9e7502024-12-26WarningsExact identifier
application number: M001
HEB Extra Strength Smooth Antacid PeppermintCALCIUM CARBONATEH E Bd04e691e-6d1c-4c39-9504-7ac0f1bd197d2024-12-26WarningsExact identifier
application number: M001
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEH E Bf294cf44-fb21-4b2e-8b7c-efd41416c6b22024-12-26WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATETrifecta Pharmaceuticals USA LLC14a7916e-5363-7f1b-e063-6294a90a20aa2024-12-20WarningsExact identifier
application number: M001
maximum strength antacid cherryALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFId6b49f0a-cf05-4b1b-8cad-c5795aa316452024-12-20WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid PeppermintCALCIUM CARBONATEGoodSense04950b56-7760-4b6c-8110-86b6a3f795b42024-12-19WarningsExact identifier
application number: M001
Goodsense Regular Strength Antacid PeppermintCALCIUM CARBONATEGoodSense32c04f3e-59f3-44aa-ad92-6724449827102024-12-19WarningsExact identifier
application number: M001
GOODSENSE Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSensead4d51f6-b55b-45db-b034-fb3da54fbe992024-12-19WarningsExact identifier
application number: M001
TUMS Extra Strength Sugar-FreeCALCIUM CARBONATEHaleon US Holdings LLC3495102f-55d2-4a94-8d55-f46f49e00c272024-12-19WarningsExact identifier
application number: M001
Goodsense Extra Strength Antacid Assorted FruitCALCIUM CARBONATEGoodSenseae6270fc-0f8d-4bba-8f12-adba3f07f7c52024-12-19WarningsExact identifier
application number: M001
Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry AntacidCALCIUM CARBONATEChain Drug Marketing Association Inc.ec729051-72d3-4d1a-8e39-d4495d5c1cf32024-12-18WarningsExact identifier
application number: M001
Guardian Extra Strength AntacidCALCIUM CARBONATEGuardian Drug Companyaef3d830-c5c3-4f72-86ba-d31945a756db2024-12-18WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN2a6be8a6-3221-4675-b41c-dd795a436fd58
308907calcium carbonate 500 MG Chewable TabletSCD2a6be8a6-3221-4675-b41c-dd795a436fd58
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY2a6be8a6-3221-4675-b41c-dd795a436fd58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68998-101-5068998010150150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68998-101-50) 2019-04-180000-00-00NoNoCurrent