Home NDC 55758-331-07 Rapidol Stomach Relief
Product NDC 55758-331
Requested package NDC 55758-331-07
11-digit product format 557580331
Labeler code 55758
Product ID 55758-331_273676c9-a1f3-b2ca-e063-6294a90ad6e5
Type HUMAN OTC DRUG
Nonproprietary name BISMUTH SUBSALICYLATE
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-08
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
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 Rapidol Stomach Relief
Listing expiration 2026-12-31 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 55758-331-07 Rapidol Stomach Relief 237 mL in 1 BOTTLE LIQUID 237 3 55758-331-08 Rapidol Stomach Relief 240 mL in 1 BOTTLE LIQUID 240 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-331 RAPIDOL STOMACH RELIEF (BISMUTH SUBSALICYLATE) LIQUID [PHARMADEL LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241120_efba1aea-f468-4f63-e053-2995a90a545b.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 Sample Exclude flag Status 55758-331-07 55758033107 237 mL in 1 BOTTLE (55758-331-07) 237 ml 2023-02-08 No No Current