Home NDC 69168-999 Gastrobiz
Product NDC 69168-999
11-digit product format 691680999
Labeler code 69168
Product ID 69168-999_b84b5c7b-afd7-4d0c-8db6-eda1bf813a75
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Allegiant Health
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-07-04
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
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 Gastrobiz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 262 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 62TEY51RR1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308761 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-999-98 Gastrobiz 1 in 1 CELLO PACK TABLET, CHEWABLE 1 9 69168-999-98 Gastrobiz 30 in 1 CARTON TABLET, CHEWABLE 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-999 GASTROBIZ (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [ALLEGIANT HEALTH] 8 Current NDC, Legacy NDC, 2 package rows 20241206_aa516512-afd7-453f-9c73-5fa930cafac3.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 12 · 223 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69168-999-98 69168099998 30 CELLO PACK in 1 CARTON (69168-999-98) / 1 TABLET, CHEWABLE in 1 CELLO PACK 30 cello pack 2022-06-30 0000-00-00 No No Current