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 29 of 42 · 833 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE Walgreens c8ea170b-57b5-4643-ba88-4cf2ae1bf6a0 2024-12-23 Warnings Exact identifier application number: M007 Sennosides SENNOSIDES Meijer, Inc. b09a234e-962d-49fc-a72e-898547b2f099 2024-12-23 Warnings Exact identifier application number: M007 Pedia-Lax GLYCERIN C.B. Fleet Company, Inc. 4e15f6ca-a40c-485f-be3f-07c2ed7cb498 2024-12-23 Warnings Exact identifier application number: M007 Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equate SENNOSIDES Wal-Mart Stores Inc 10dc8b4d-8136-44a5-a2ce-30295866cd3b 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best Choice SENNOSIDES Valu Merchandisers Company 4b7cab4b-a610-4fb9-ac31-011975f1b29c 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG health SENNOSIDES Dolgencorp Inc. 88dc2f9b-18ca-4e21-8faa-5339f82a2a75 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare health SENNOSIDES Topco Associates f051b302-f70e-4ab6-bb69-f69b45f2642e 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE C.D.M.A., Inc. e80be2b6-a0ca-4838-b956-a1debb065d57 2024-12-23 Warnings Exact identifier application number: M007 Conlax BISACODYL Bliss GVS Pharma Limited 7d25990b-6f7c-1eac-e053-2a91aa0a7022 2024-12-21 Warnings Exact identifier application number: M007 GeriCare Docusate Sodium Liquid DOCUSATE SODIUM GERI-CARE PHARMACEUTICALS, CORP e50558e1-f0c8-4b03-9109-6a273b61730d 2024-12-20 Warnings Exact identifier application number: M007 SENNA Syrup SENNOSIDES A AND B SDA Laboratories, Inc. cfc6ab2f-5376-46fc-ac58-7dedd7010006 2024-12-20 Warnings Exact identifier application number: M007 Fiber Therapy CALCIUM POLYCARBOPHIL Wal-Mart Stores, Inc. 3432a4a6-aeb1-4a72-8451-5903266931fa 2024-12-20 Warnings Exact identifier application number: M007 Fiber Laxative CALCIUM POLYCARBOPHIL UNITED NATURAL FOODS, INC. DBA UNFI f7236bbc-8ded-4e11-8cce-b0a2255e1450 2024-12-20 Warnings Exact identifier application number: M007 Fiber Caps CALCIUM POLYCARBOPHIL Guardian Drug Company 31e6b0c7-1d4a-4660-ae87-9d18e0001dcd 2024-12-19 Warnings Exact identifier application number: M007 Epsom Salts MAGNESIUM SULFATE NEW PRIDE CORP f6626023-4857-518b-e053-2a95a90a9821 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA CHERRY MAGNESIUM HYDROXIDE WALGREEN COMPANY 5fae9b56-2555-b583-e053-2991aa0a8d59 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA MAGNESIUM HYDROXIDE WALGREEN COMPANY 5faf2ed0-dd71-17c9-e053-2a91aa0ab75a 2024-12-19 Warnings Exact identifier application number: M007 Stimulant Laxative Plus Stool Softener DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG RUGBY LABORATORIES f5afd8eb-d35d-44ab-897d-1d41c98ca138 2024-12-19 Warnings Exact identifier application number: M007 Goodsense Fiber METHYLCELLULOSE GoodSense 96ed1ba1-7f91-4912-a549-a4be2c3e0362 2024-12-19 Warnings Exact identifier application number: M007 Senexon-S DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG RUGBY LABORATORIES 2e758ff1-3083-4245-8f58-1c47b042bfdd 2024-12-19 Warnings Exact identifier application number: M007
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