Home NDC 84540-522 R Cos
Product NDC 84540-522
11-digit product format 845400522
Labeler code 84540
Product ID 84540-522_3d539cd6-a948-369c-e063-6294a90add5f
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form TABLET
Route ORAL
Labeler NPG Bio Pharmaceuticals Co.,Ltd.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-11
Substance CALCIUM CARBONATE
Active strength 90 mg/500mg
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 R Cos
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 90 mg/500mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84540-522-01 R Cos 500 mg in 1 BLISTER PACK TABLET 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84540-522 R COS (CALCIUM CARBONATE) TABLET [NPG BIO PHARMACEUTICALS CO.,LTD.] 3 Current NDC, 1 package rows 20241223_21fa767a-1344-5ed9-e063-6394a90a5fe6.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 25 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. edcb8451-6fa7-4bc2-95f6-2a0806f7f3da 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 576660ed-203a-4842-9d39-c5be10daf976 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 1796b3ec-833a-4cf1-ba50-bc4da827f84f 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. d923fa75-f556-45e3-9f52-39a62e89984b 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. cd3ede8c-2c77-4d81-8dff-8198025a2156 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f5f9b-4192-15e6-e053-2995a90a6457 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC 2b494372-de59-e462-e063-6294a90a08da 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City a225d515-430d-4e34-846c-0bfec3e74109 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 372f99c9-4ad3-4631-b8c8-2a34c47343cc 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 Warnings Exact identifier application number: M022
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84540-522-01 84540052201 500 mg in 1 BLISTER PACK (84540-522-01) 500 mg 2024-09-11 No No Current