FDA.reportPublic FDA data

Docusate Sodium

Product NDC
55289-493
11-digit product format
552890493
Labeler code
55289
Product ID
55289-493_419aeba7-0cd0-2a17-e063-6394a90a2279
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M007
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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

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

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 capsule2023-05-18NoNoHistorical
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