Home NDC 80425-0345 Laxacin
Product NDC 80425-0345
11-digit product format 804250345
Labeler code 80425
Product ID 80425-0345_2a9c2eb6-a6dc-f647-e063-6294a90a93fe
Type HUMAN OTC DRUG
Nonproprietary name Docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-19
Substance DOCUSATE SODIUM; SENNOSIDES A AND B
Active strength 50; 8.6 mg/1; 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 Laxacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 mg/1 SENNOSIDES A AND B 8.6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup 1B5FPI42EN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998740 Internal RxNorm lookup 2106884 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0345-1 Laxacin 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0345 LAXACIN (DOCUSATE SODIUM AND SENNOSIDES) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 1 package rows 20250102_fe7d4d75-0f8a-1e7d-e053-6394a90afb4d.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 14 of 42 · 833 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 80425-0345-1 80425034501 100 TABLET in 1 BOTTLE (80425-0345-1) 100 tablet 2023-06-19 No No Current