FDA.reportPublic FDA data

Docusate Sodium

Product NDC
16103-399
11-digit product format
161030399
Labeler code
16103
Product ID
16103-399_43b71fc6-6af3-4f45-a946-ab9cff49f5ba
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 100mg
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharbest 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

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-399-082026-01-29C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112026-01-29C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-082024-01-19C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112024-01-19C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-082022-01-28C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels
16103-399-112022-01-28C16284748780-1d6a99b39-9e61-a426-e053-dadaa90af4c2Docusate Sodium 100 mg Softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-399-08Docusate Sodium100 in 1 BOTTLECAPSULE1003
16103-399-11Docusate Sodium1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-399-08EA - Each16103-399463d6a62-9936-4856-91dd-fe23717ceae512019-04-11
16103-399-11EA - Each16103-3990cad9fe1-9128-4221-bb7b-c73e708258bb12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-399DOCUSATE SODIUM (DOCUSATE SODIUM 100MG) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20240120_025e03e0-e273-47ed-87f7-98e388abe047.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
1115005docusate sodium 100 MG Oral CapsulePSN025e03e0-e273-47ed-87f7-98e388abe0473
1115005docusate sodium 100 MG Oral CapsuleSCD025e03e0-e273-47ed-87f7-98e388abe0473
1115005DOSS Sodium 100 MG Oral CapsuleSY025e03e0-e273-47ed-87f7-98e388abe0473
1115005docusate sodium 100 MG Oral CapsulePSN1b2f2afd-1e8a-058c-e063-6294a90a24ff2
1115005docusate sodium 100 MG Oral CapsuleSCD1b2f2afd-1e8a-058c-e063-6294a90a24ff2
1115005DOSS Sodium 100 MG Oral CapsuleSY1b2f2afd-1e8a-058c-e063-6294a90a24ff2
1115005docusate sodium 100 MG Oral CapsulePSN09376e58-c50a-4eda-ab2a-b980a4b65dc01
1115005docusate sodium 100 MG Oral CapsuleSCD09376e58-c50a-4eda-ab2a-b980a4b65dc01
1115005DOSS Sodium 100 MG Oral CapsuleSY09376e58-c50a-4eda-ab2a-b980a4b65dc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-399-0816103039908100 CAPSULE in 1 BOTTLE (16103-399-08) 100 capsule2016-03-010000-00-00NoNoCurrent
16103-399-11161030399111000 CAPSULE in 1 BOTTLE (16103-399-11) 1000 capsule2016-03-010000-00-00NoNoCurrent