FDA.reportPublic FDA data

Saline Laxative

Product NDC
0363-0005
Requested package NDC
0363-0005-39
11-digit product format
003630005
Labeler code
0363
Product ID
0363-0005_595d2f7b-9869-4950-91de-dac9b95a0cf4
Type
HUMAN OTC DRUG
Nonproprietary name
sodium phosphate
Dosage form
ENEMA
Route
RECTAL
Labeler
Walgreen Company
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-31
Substance
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength
7; 19 g/118mL; g/118mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 7 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Saline Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g/118mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g/118mL

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
fb260df0-7bda-4299-84a5-44c8f9447798Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-0005-112025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-202025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-362025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-372025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-382025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-392025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-402025-06-19WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-112025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-202025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-362025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-372025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-382025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-392025-01-30WALGREENS READY TO USE ENEMA LAXATIVE
0363-0005-402025-01-30WALGREENS READY TO USE ENEMA LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0005-37Saline Laxative133 mL in 1 BOTTLEENEMA13310
0363-0005-37Saline Laxative1 in 1 BOXENEMA110
0363-0005-38Saline Laxative133 mL in 1 BOTTLEENEMA13310
0363-0005-38Saline Laxative3 in 1 BOXENEMA310
0363-0005-39Saline Laxative133 mL in 1 BOTTLEENEMA13310
0363-0005-39Saline Laxative6 in 1 BOXENEMA610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0005-11ML - Milliliter0363-000595554ed6-4e86-4ca4-81d2-c0ff58454fa612024-05-16
0363-0005-20ML - Milliliter0363-0005e1538b58-b098-4cdd-9dcb-14fea943c60c12020-01-03
0363-0005-37ML - Milliliter0363-0005821e39b2-ef41-484a-80b6-53009c4ba6fe12022-06-06
0363-0005-38ML - Milliliter0363-000524d6ee2d-3c6e-4cb7-9665-7a31df6e3cc012022-06-06
0363-0005-39ML - Milliliter0363-0005cd206d47-de4a-4c3f-86d7-a4a07cf369d712022-06-06
0363-0005-40ML - Milliliter0363-0005969cc19d-3350-4107-9907-abb8449ce9ee12019-12-10

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0005SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [WALGREEN COMPANY]9Current NDC, Legacy NDC, 6 package rows20210326_fb260df0-7bda-4299-84a5-44c8f9447798.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 1 of 44 · 872 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-04WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact 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 EnemaPSNfb260df0-7bda-4299-84a5-44c8f944779810
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCDfb260df0-7bda-4299-84a5-44c8f944779810
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSYfb260df0-7bda-4299-84a5-44c8f944779810
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSYfb260df0-7bda-4299-84a5-44c8f944779810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0005-39003630005396 BOTTLE in 1 BOX (0363-0005-39) / 133 mL in 1 BOTTLE6 bottle2016-03-110000-00-00NoNoCurrent