FDA.reportPublic FDA data

Saline Laxative

Product NDC
0904-6320
11-digit product format
009046320
Labeler code
0904
Product ID
0904-6320_8d595efb-9d1d-48d0-8660-2e83df819c7d
Type
HUMAN OTC DRUG
Nonproprietary name
Saline Laxative
Dosage form
ENEMA
Route
RECTAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-11
Marketing end
2027-04-30
Substance
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength
7; 19 g/133mL; g/133mL
NDC exclude flag
No
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
Saline Laxative

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g/133mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g/133mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GR686LBA74Internal UNII lookup
3980JIH2SWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283100Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b3758ffe-1bac-4df6-9714-5e33e9d28d90Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6320-78Saline Laxative133 mL in 1 BOTTLEENEMA1339

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6320-78ML - Milliliter0904-63203de6133e-b46b-4d03-a490-34409f8904b412014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA74SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWSALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RSALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6320SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20250101_b3758ffe-1bac-4df6-9714-5e33e9d28d90.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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
application number: M007
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
application number: M007
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
application number: M007
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
application number: M007
SennaSENNARugby Laboratories41d53783-7ac2-411c-b9bf-afd87b3af30d2026-04-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI95bae7bf-f240-4674-9e3c-640a603fdc352026-04-15WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.a4b442f1-d5a6-4cbf-b371-1f6639634f802026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.267c434d-3034-491b-b4b1-1d0cbacb16152026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B84116db2-a7b7-460a-a5e5-8558bd4247812026-04-02WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
application number: M007
Castor OilCASTOR OILSTRATEGIC SOURCING SERVICES4db6736f-416a-f142-e063-6394a90ab08f2026-04-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEFarmacias De Similares TX LLC4e6a64a0-e453-709b-e063-6294a90a74432026-04-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals93ef6486-0930-41e3-a2c6-44af7e37e98b2026-03-31WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSNb3758ffe-1bac-4df6-9714-5e33e9d28d909
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCDb3758ffe-1bac-4df6-9714-5e33e9d28d909
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSYb3758ffe-1bac-4df6-9714-5e33e9d28d909
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSYb3758ffe-1bac-4df6-9714-5e33e9d28d909

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6320-7800904632078133 mL in 1 BOTTLE (0904-6320-78) 133 ml2013-07-112027-04-30NoNoCurrent