Home NDC 53041-021 Guardian Pink Bismuth
Product NDC 53041-021
11-digit product format 530410021
Labeler code 53041
Product ID 53041-021_657ef596-d643-4c06-993d-001a5770cf91
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Guardian Drug Company
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-10-08
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
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 Guardian Pink Bismuth
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53041-021-41 Guardian Pink Bismuth 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 3 53041-021-41 Guardian Pink Bismuth 5 in 1 BOX TABLET, CHEWABLE 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-021 GUARDIAN PINK BISMUTH (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20241220_7e83fdf2-4007-46a8-ae9d-eab5a8ff1915.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 4 of 10 · 198 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 53041-021-41 53041002141 5 BLISTER PACK in 1 BOX (53041-021-41) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 5 blister pack 2021-10-08 0000-00-00 No No Current