FDA.reportPublic FDA data

Docusate Mini Enema

Product NDC
0904-6920
11-digit product format
009046920
Labeler code
0904
Product ID
0904-6920_4524d961-37c9-20b3-e063-6294a90a54d0
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
LIQUID
Route
RECTAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-26
Substance
DOCUSATE SODIUM
Active strength
283 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Mini Enema
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM283 mg/5mL

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
1190184Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91099e15-94d7-b684-e053-2a95a90a574eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6920-93Docusate Mini Enema5 mL in 1 TUBELIQUID59
0904-6920-93Docusate Mini Enema30 in 1 JARLIQUID309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6920-93ML - Milliliter0904-6920fc220a58-bf2c-4750-8e0c-26561da84b5e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6920DOCUSATE MINI ENEMA (DOCUSATE SODIUM) LIQUID [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20241107_91099e15-94d7-b684-e053-2a95a90a574e.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 26 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
application number: M007
LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c5c1e6-3123-c802-e053-2995a90aa0732025-02-12WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c529e4-6738-377c-e053-2995a90aaf382025-02-12WarningsExact identifier
application number: M007
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
application number: M007
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
application number: M007
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
application number: M007
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
application number: M007
LAX-TIMESENNOSIDESTIME CAP LABORATORIES, INC74a627fc-00e5-eb78-e053-2991aa0abacc2025-02-08WarningsExact identifier
application number: M007
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALMART INC.26b9f247-c242-2925-e063-6394a90a68dd2025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
application number: M007
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190184docusate sodium 283 MG in 5 mL EnemaPSN91099e15-94d7-b684-e053-2a95a90a574e9
1190184docusate sodium 56.6 MG/ML EnemaSCD91099e15-94d7-b684-e053-2a95a90a574e9
1190184DOSS sodium 283 MG per 5 ML EnemaSY91099e15-94d7-b684-e053-2a95a90a574e9
1190184DOSS Sodium 56.6 MG/ML EnemaSY91099e15-94d7-b684-e053-2a95a90a574e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6920-930090469209330 TUBE in 1 JAR (0904-6920-93) / 5 mL in 1 TUBE30 tube2019-08-260000-00-00NoNoCurrent