DOCUSATE SODIUM 100mg Two-Tone
- Product NDC
- 53345-023
- 11-digit product format
- 533450023
- Labeler code
- 53345
- Product ID
- 53345-023_27c7853d-1060-f670-e063-6394a90aa99f
- 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
- 2014-08-11
- 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 |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115005 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a923e5ca-86fd-4bf9-9931-180ddfdeae66 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-023-02 | DOCUSATE SODIUM 100mg Two-Tone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 53345-023-02 | DOCUSATE SODIUM 100mg Two-Tone | 15000 in 1 BAG | CAPSULE, LIQUID FILLED | 15000 | 5 | |
| 53345-023-01 | DOCUSATE SODIUM 100mg Two-Tone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 53345-023-01 | DOCUSATE SODIUM 100mg Two-Tone | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-023 | DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241127_7cf1df18-d658-4bff-8a62-365fc5656942.zip |
| 53345-023 | DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_a923e5ca-86fd-4bf9-9931-180ddfdeae66.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Publix Fiber Therapy Sugar Free | PSYLLIUM HUSK | PUBLIX SUPER MARKETS, INC | ed3dc80a-a243-4013-9886-b148e3e3b662 | 2025-10-28 | Warnings | M007 |
| Childrens Oral Saline Laxative | MAGNESIUM HYDROXIDE | WAL-MART STORES,INC., | a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc | 2025-10-27 | Warnings | M007 |
| equate Fiber Therapy | METHYLCELLULOSE | Wal-Mart Stores,Inc., | 7acc30b4-e946-42cd-8eec-cf15159d478d | 2025-10-27 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | 5e97aa5b-62e2-0664-e053-2a91aa0ac341 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | H E B | 3d03ce42-e671-6d76-e054-00144ff8d46c | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | CVS Pharmacy | c56e010a-7503-3e1c-e053-2a95a90a2b85 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Consortium LLC | 022dd494-cb3c-4fa7-be99-4c38fabdc612 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | 5e97c4d2-e41d-5bb6-e053-2a91aa0a3163 | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Major Pharmaceuticals | c194c40c-c732-2f03-e053-2a95a90a7a40 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | CVS Pharmacy | 94e4a6f3-43d0-b2a5-e053-2a95a90aa115 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Chain Drug Marketing Association Inc. | 5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Rite Aid Corporation | 5da2ea79-f3bc-b82b-e053-2a91aa0af0af | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Pharmacy Value Alliance LLC | 8a6d6729-f6eb-4f68-e053-2a95a90a5c9e | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Rite Aid Corporation | 5da2ea79-f37a-b82b-e053-2a91aa0af0af | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | DSC Laboratories Inc. | a381838b-d1ae-11c5-e053-2a95a90a7bcb | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Amerisource Bergen/Good Neighbor Pharmacy | 90a4d385-d548-420b-91d2-54d5e819fcce | 2025-10-24 | Warnings | M007 |
| Bisacodyl | BISACODYL | Cardinal Health | c2b33e78-6ab7-1785-e053-2995a90a9c4f | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | CVS Pharmacy | 3a59c4a9-5f86-406a-e054-00144ff8d46c | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Cardinal Health | 7e7e9366-af1e-e0ff-e053-2a91aa0a9487 | 2025-10-24 | Warnings | M007 |
| Glycerin | GLYCERIN | Cardinal Health | c2b02afc-5a8a-2a25-e053-2a95a90ae45c | 2025-10-24 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | 7cf1df18-d658-4bff-8a62-365fc5656942 | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | 7cf1df18-d658-4bff-8a62-365fc5656942 | 5 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | 7cf1df18-d658-4bff-8a62-365fc5656942 | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 3 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 3 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-023-01 | 53345002301 | 1 BAG in 1 BOX (53345-023-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-08-11 | 0000-00-00 | No | No | Current |
| 53345-023-02 | 53345002302 | 1 BAG in 1 BOX (53345-023-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2015-04-10 | 0000-00-00 | No | No | Current |