FDA.reportPublic FDA data

Calcium Carbonate

Product NDC
68071-2258
11-digit product format
680712258
Labeler code
68071
Product ID
68071-2258_1d76957a-baf7-0eb0-e063-6294a90aaadd
Type
HUMAN OTC DRUG
Nonproprietary name
Antacid Tablets
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-12
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
2026-12-31
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
Calcium Carbonate
Brand name suffix
Assorted Flavors
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CARBONATE500 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
308907Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af10dfb6-fef3-3410-e053-2995a90a9130Available 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
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2258-5Calcium CarbonateAssorted Flavors150 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2258CALCIUM CARBONATE ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240726_af10dfb6-fef3-3410-e053-2995a90a9130.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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSNaf10dfb6-fef3-3410-e053-2995a90a91303
308907calcium carbonate 500 MG Chewable TabletSCDaf10dfb6-fef3-3410-e053-2995a90a91303
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSYaf10dfb6-fef3-3410-e053-2995a90a91303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2258-568071225805150 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (68071-2258-5) 2020-09-110000-00-00NoNoCurrent