Home NDC 68163-100 Regular Strength
Product NDC 68163-100
11-digit product format 681630100
Labeler code 68163
Product ID 68163-100_407dc7a8-9be0-4c77-a47b-7eacb1986f46
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler RARITAN PHARMACEUTICALS INC
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-15
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 Tropical Fruit
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 500 mg/1
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308907 Internal RxNorm 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 68163-100-66 Regular StrengthTropical Fruit 66 in 1 BOTTLE TABLET, CHEWABLE 66 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-100 REGULAR STRENGTH TROPICAL FRUIT (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC] 6 Current NDC, Legacy NDC, 1 package rows 20241123_38c6cece-71a0-40d8-bfc8-2f6467f9239b.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 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68163-100-66 68163010066 66 TABLET, CHEWABLE in 1 BOTTLE (68163-100-66) 2019-05-15 0000-00-00 No No Current