Home NDC 68163-706 Regular Strength
Product NDC 68163-706
11-digit product format 681630706
Labeler code 68163
Product ID 68163-706_3be9b201-0149-414f-835c-de913d3d0593
Type HUMAN OTC DRUG
Nonproprietary name Bismuth subsalicylate
Dosage form SUSPENSION
Route ORAL
Labeler Raritan Pharmaceuticals Inc
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-13
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
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 Pink Bismuth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/30mL
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 68163-706-04 Regular StrengthPink Bismuth 118 mL in 1 BOTTLE SUSPENSION 118 8 68163-706-12 Regular StrengthPink Bismuth 354 mL in 1 BOTTLE SUSPENSION 354 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68163-706 REGULAR STRENGTH PINK BISMUTH (BISMUTH SUBSALICYLATE) SUSPENSION [RARITAN PHARMACEUTICALS INC] 7 Current NDC, Legacy NDC, 2 package rows 20241124_89d18117-f0af-408a-a5ae-19da84158806.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 68163-706-04 68163070604 118 mL in 1 BOTTLE (68163-706-04) 118 ml 2019-05-13 0000-00-00 No No Current 68163-706-12 68163070612 354 mL in 1 BOTTLE (68163-706-12) 354 ml 2019-05-13 0000-00-00 No No Current