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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-399-11fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-399-08fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-399-1186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-399-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-399-11bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-399-08bd6a592717d7…303034d00443…

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
025e03e0-e273-47ed-87f7-98e388abe047Available on FDA.report

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, Related label table
NDCEffectiveRelated label
16103-399-082026-01-29Docusate Sodium 100 mg Softgels
16103-399-112026-01-29Docusate Sodium 100 mg Softgels
16103-399-082024-01-19Docusate Sodium 100 mg Softgels
16103-399-112024-01-19Docusate Sodium 100 mg Softgels
16103-399-082022-01-28Docusate Sodium 100 mg Softgels
16103-399-112022-01-28Docusate 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

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
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