FDA.reportPublic FDA data

DOCUZEN

Product NDC
71205-282
11-digit product format
712050282
Labeler code
71205
Product ID
71205-282_3e549d03-823e-4fbe-935a-e9f7de196abc
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides 8.6mg and Docusate Sodium 50mg
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-27
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 mg/1; 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
DOCUZEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1
DOCUSATE SODIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92879e62-f60a-4ab4-9532-610cdd2628eeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-282-30DOCUZEN30 in 1 BOTTLE, PLASTICTABLET305
71205-282-60DOCUZEN60 in 1 BOTTLE, PLASTICTABLET605
71205-282-90DOCUZEN90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-282-60EA - Each71205-28236f476f3-c022-4fce-9203-aebc9ed5390e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-282DOCUZEN (SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG) TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20231118_92879e62-f60a-4ab4-9532-610cdd2628ee.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 21 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fiber Therapy Sugar FreePSYLLIUM HUSKPUBLIX SUPER MARKETS, INCed3dc80a-a243-4013-9886-b148e3e3b6622025-10-28WarningsExact identifier
application number: M007
Childrens Oral Saline LaxativeMAGNESIUM HYDROXIDEWAL-MART STORES,INC.,a2eb50ab-851a-4abb-a12f-6d9d8b0cb6bc2025-10-27WarningsExact identifier
application number: M007
equate Fiber TherapyMETHYLCELLULOSEWal-Mart Stores,Inc.,7acc30b4-e946-42cd-8eec-cf15159d478d2025-10-27WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCVS Pharmacyc56e010a-7503-3e1c-e053-2a95a90a2b852025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLMajor Pharmaceuticalsc194c40c-c732-2f03-e053-2a95a90a7a402025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLPharmacy Value Alliance LLC8a6d6729-f6eb-4f68-e053-2a95a90a5c9e2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
application number: M007
BisacodylBISACODYLCardinal Healthc2b33e78-6ab7-1785-e053-2995a90a9c4f2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
application number: M007
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN92879e62-f60a-4ab4-9532-610cdd2628ee5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD92879e62-f60a-4ab4-9532-610cdd2628ee5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY92879e62-f60a-4ab4-9532-610cdd2628ee5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-282-307120502823030 TABLET in 1 BOTTLE, PLASTIC (71205-282-30) 30 tablet2019-06-010000-00-00NoNoCurrent
71205-282-607120502826060 TABLET in 1 BOTTLE, PLASTIC (71205-282-60) 60 tablet2019-06-010000-00-00NoNoCurrent
71205-282-907120502829090 TABLET in 1 BOTTLE, PLASTIC (71205-282-90) 90 tablet2019-06-010000-00-00NoNoCurrent