FDA.reportPublic FDA data

Docusate Sodium

Product NDC
55289-493
11-digit product format
552890493
Labeler code
55289
Product ID
55289-493_54129d13-ffb2-2e6d-e063-6394a90a6290
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66ca7a94-378b-4476-8060-d9c6f82f57fcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-493-01Docusate Sodium100 in 1 BOTTLE, PLASTICCAPSULE10019
55289-493-12Docusate Sodium12 in 1 BOTTLE, PLASTICCAPSULE1219
55289-493-14Docusate Sodium14 in 1 BOTTLE, PLASTICCAPSULE1419
55289-493-30Docusate Sodium30 in 1 BOTTLE, PLASTICCAPSULE3019
55289-493-60Docusate Sodium60 in 1 BOTTLE, PLASTICCAPSULE6019
55289-493-90Docusate Sodium90 in 1 BOTTLE, PLASTICCAPSULE9019
55289-493-93Docusate Sodium180 in 1 BOTTLE, PLASTICCAPSULE18019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-493-01EA - Each55289-4933c49bdc5-bd16-4d64-91f8-2678df40de7212023-06-06
55289-493-12EA - Each55289-49323f7085f-daef-48e6-87f0-8403f94df9b412021-05-05
55289-493-14EA - Each55289-493b613e57f-640f-4f63-a125-120bb2247d6d12018-04-19
55289-493-30EA - Each55289-4934f9252c6-8cec-468c-8398-30f72580f94712018-04-19
55289-493-60EA - Each55289-493079ae045-5df5-4b00-a74c-90e64c52be1e12018-04-19
55289-493-90EA - Each55289-493c575b1bb-c86e-436f-9610-e24584257f6412018-04-19
55289-493-93EA - Each55289-493b3bfe6d0-cc05-415c-aa3a-e7179ecec52e12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-493DOCUSATE SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 7 package rows20240314_66ca7a94-378b-4476-8060-d9c6f82f57fc.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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERASTAT, CHERRYCHERRY COUGH DROPSHART Healthe3fdd1de-8f28-4063-a590-6c44507dead12025-12-23WarningsExact identifier
application number: M
Crystal Clean Antibacterial HandSoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation308969b5-5ab2-44ef-ac70-9518a5dfbee22025-12-22WarningsExact identifier
application number: M
Foaming Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporationeed9b007-0dc1-4954-891f-a7a042e763aa2025-12-22WarningsExact identifier
application number: M
Antibacterial HandsoapBENZALKONIUM CHLORIDEChemcor Chemical Corporation1022be5e-d515-4a06-bf2b-65774ec29a0b2025-12-22WarningsExact identifier
application number: M
Healthy Hands Foaming Hand SanitizerN/AMaintex746650b8-74b7-43f0-bdfc-62a68764f9362025-12-22WarningsExact identifier
application number: M
Chemcor Chemical Foaming Hand SanitizerBENZALKONIUM CHLORIDEChemcor Chemical Corporation5c9d90c1-0381-4237-9529-398fa51b3ab42025-12-22WarningsExact identifier
application number: M
Fresh HandsBENZALKONIUM CHLORIDEMaintexe174083a-8820-4fa7-8cc2-0a2c86f27cd62025-12-22WarningsExact identifier
application number: M
Aluminum HydroxideALUMINUM HYDROXIDEATLANTIC BIOLOGICALS CORP.60a54d4e-89c2-4329-86bf-a288527f37b52025-12-15WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.ff1f6f82-0c7c-4e3f-a2bd-3185e16fa7702025-12-10WarningsExact identifier
application number: M
Health One Pain Relief Cream with Lidocaine 4%PAIN RELIEF CREAM WITH LIDOCAINE 4%ONE2ZEE LIMITED LIABILITY COMPANY46a2276f-9da0-4e41-92f0-b17c302c72222025-12-03WarningsExact identifier
application number: M
Health One Deep Relieving GelDEEP RELIEVING GELONE2ZEE LIMITED LIABILITY COMPANY41d837f1-09e4-4ce3-8c1a-725c2147c7de2025-12-03WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
application number: M
AB 3000BENZALKONIUM CHLORIDEChemco892c8911-9f1a-4c0c-9106-6d9a90d577a92025-11-06WarningsExact identifier
application number: M
Strike Bac Antibacterial HandBENZALKONIUM CHLORIDEGenlabs Corporation4014aa67-8016-40c5-88ec-daec9dba4f452025-11-06WarningsExact identifier
application number: M
Metro Antimicrobial HandBENZALKONIUM CHLORIDEMaintexa84d83dd-2445-4d0f-b763-2c69e8248cf92025-11-06WarningsExact identifier
application number: M
Butler Clean HandsBENZALKONIUM CHLORIDEMaintex3fd526a8-d197-4a12-b51b-165e706720a72025-11-06WarningsExact identifier
application number: M
First Street Dishwashing Concentrate and Antibacterial HandBENZALKONIUM CHLORIDEAmerifoods Trading Companyfc81ef1a-db55-411e-8b25-7dd59dd38eda2025-11-06WarningsExact identifier
application number: M
Champion Ultra CleanBENZALKONIUM CHLORIDEMaintex47426f67-af14-4b42-8ada-11b3648269492025-11-06WarningsExact identifier
application number: M
Premium Protection Antibacterial HandBENZALKONIUM CHLORIDEMaintex53bd6860-dde3-4525-ba1b-50f69be09abc2025-11-06WarningsExact identifier
application number: M
Hy-G-ClenzBENZALKONIUM CHLORIDEMicronova Manufacturing, Inc.ce96634e-1ce8-4244-b317-8e1da249de832025-11-06WarningsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN66ca7a94-378b-4476-8060-d9c6f82f57fc19
1115005docusate sodium 100 MG Oral CapsuleSCD66ca7a94-378b-4476-8060-d9c6f82f57fc19
1115005DOSS Sodium 100 MG Oral CapsuleSY66ca7a94-378b-4476-8060-d9c6f82f57fc19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-493-0155289049301100 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-01) 100 capsule2023-05-18NoNoCurrent
55289-493-125528904931212 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-12) 12 capsule2021-04-210000-00-00NoNoCurrent
55289-493-145528904931414 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-14) 14 capsule2018-01-120000-00-00NoNoCurrent
55289-493-305528904933030 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-30) 30 capsule2018-01-122038-01-31NoNoCurrent
55289-493-605528904936060 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-60) 60 capsule2018-01-120000-00-00NoNoCurrent
55289-493-905528904939090 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-90) 90 capsule2018-01-120000-00-00NoNoCurrent
55289-493-9355289049393180 CAPSULE in 1 BOTTLE, PLASTIC (55289-493-93) 180 capsule2023-03-282038-01-31NoNoCurrent