Home NDC 54629-601 Docusate Sodium
Product NDC 54629-601
11-digit product format 546290601
Labeler code 54629
Product ID 54629-601_16a5df9c-f9e1-49dc-99cb-b21dfd97e1bf
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler National Vitamin Company
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2000-05-01
Marketing end 2027-10-31
Substance DOCUSATE SODIUM
Active strength 250 mg/1
NDC exclude flag No
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 Docusate Sodium Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1245468 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54629-601-01 Docusate Sodium 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 3 54629-601-99 Docusate Sodium 1000 in 1 BOTTLE CAPSULE, LIQUID FILLED 1000 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54629-601 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY] 3 Current NDC, Legacy NDC, 2 package rows 20241228_0c66642c-82cb-42cd-82bb-5f95852cc5d1.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 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54629-601-01 54629060101 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-01) 2000-05-01 2027-10-31 No No Current 54629-601-99 54629060199 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-99) 2000-05-01 2027-10-31 No No Current