Home NDC 55259-1191 Prevent Restoration
Product NDC 55259-1191
11-digit product format 552591191
Labeler code 55259
Product ID 55259-1191_11df6e71-201d-327a-e063-6294a90aec6a
Type HUMAN OTC DRUG
Nonproprietary name oyster shell
Dosage form TABLET
Route ORAL
Labeler APEXEL CO., LTD.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2020-09-07
Substance OSTREA EDULIS SHELL
Active strength .67 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Prevent Restoration
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSTREA EDULIS SHELL .67 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 49OY13BE7Z 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 55259-1191-1 Prevent Restoration 120 in 1 BOTTLE TABLET 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55259-1191 PREVENT RESTORATION (OYSTER SHELL) TABLET [APEXEL CO., LTD.] 2 Current NDC, 1 package rows 20240222_11df6e80-3dea-ca38-e063-6394a90a31a9.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55259-1191-1 55259119101 120 TABLET in 1 BOTTLE (55259-1191-1) 120 tablet 2020-09-07 No No Current