Home NDC 53041-527 Pink-Bismuth
Product NDC 53041-527
11-digit product format 530410527
Labeler code 53041
Product ID 53041-527_13b52b6e-d8cb-476e-a8af-e6df6d02b22f
Type HUMAN OTC DRUG
Nonproprietary name Bismuth Subsalicylate
Dosage form LIQUID
Route ORAL
Labeler Guardian Drug Company
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-05-30
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/15mL
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
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 Pink-Bismuth
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 262 mg/15mL
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 308762 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 53041-527-03 Pink-Bismuth 118 mL in 1 BOTTLE LIQUID 118 6 53041-527-04 Pink-Bismuth 236 mL in 1 BOTTLE LIQUID 236 6 53041-527-05 Pink-Bismuth 354 mL in 1 BOTTLE LIQUID 354 6 53041-527-06 Pink-Bismuth 473 mL in 1 BOTTLE LIQUID 473 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53041-527 PINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY] 5 Current NDC, Legacy NDC, 4 package rows 20241220_cb7da2b4-5e44-488b-a6e7-362e9b06c49c.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 53041-527-03 53041052703 118 mL in 1 BOTTLE (53041-527-03) 118 ml 2008-05-30 0000-00-00 No No Current 53041-527-04 53041052704 236 mL in 1 BOTTLE (53041-527-04) 236 ml 2008-05-30 0000-00-00 No No Current 53041-527-05 53041052705 354 mL in 1 BOTTLE (53041-527-05) 354 ml 2008-05-30 0000-00-00 No No Current 53041-527-06 53041052706 473 mL in 1 BOTTLE (53041-527-06) 473 ml 2008-05-30 0000-00-00 No No Current