Home NDC 53345-018 DOCUSATE SODIUM 100mg Two-Tone
Product NDC 53345-018
11-digit product format 533450018
Labeler code 53345
Product ID 53345-018_2767f5d0-11e2-5dbb-e063-6394a90a364c
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-12-23
Substance DOCUSATE SODIUM
Active strength 100 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 DOCUSATE SODIUM 100mg Two-Tone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 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 1115005 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 53345-018-01 DOCUSATE SODIUM 100mg Two-Tone 1 in 1 BOX CAPSULE, LIQUID FILLED 1 5 53345-018-01 DOCUSATE SODIUM 100mg Two-Tone 20000 in 1 BAG CAPSULE, LIQUID FILLED 20000 5 53345-018-02 DOCUSATE SODIUM 100mg Two-Tone 15000 in 1 BAG CAPSULE, LIQUID FILLED 15000 5 53345-018-02 DOCUSATE SODIUM 100mg Two-Tone 1 in 1 BOX CAPSULE, LIQUID FILLED 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOCUSATE SODIUM ACTIVE INGREDIENT F05Q2T2JA0 DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 DOCUSATE ACTIVE MOIETY M7P27195AG DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-018 DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] 5 Current NDC, Legacy NDC, 4 package rows 20241122_85c64624-428d-46fa-8071-f42b8feec049.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 Marketing end Sample Exclude flag Status 53345-018-01 53345001801 1 BAG in 1 BOX (53345-018-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-12-23 0000-00-00 No No Current 53345-018-02 53345001802 1 BAG in 1 BOX (53345-018-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2013-12-23 0000-00-00 No No Current