FDA.reportPublic FDA data

Pure and Gentle Laxative

Product NDC
53329-014
11-digit product format
533290014
Labeler code
53329
Product ID
53329-014_27d44bbd-bd6d-844e-e063-6394a90a6273
Type
HUMAN OTC DRUG
Nonproprietary name
sodium phosphate
Dosage form
ENEMA
Route
RECTAL
Labeler
Medline Industries, LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-09
Substance
SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active strength
7; 19 g/118mL; g/118mL
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
Pure and Gentle Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, DIBASIC7 g/118mL
SODIUM PHOSPHATE, MONOBASIC19 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
e3165538-75dd-4f0f-adc8-d4075de10f1eAvailable 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
53329-014-11Pure and Gentle Laxative1 in 1 BOXENEMA113
53329-014-11Pure and Gentle Laxative133 mL in 1 BOTTLEENEMA13313
53329-014-58Pure and Gentle Laxative133 mL in 1 BOTTLEENEMA13313
53329-014-58Pure and Gentle Laxative24 in 1 CASEENEMA2413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-014-11ML - Milliliter53329-014880b0529-6881-4d11-8446-2e878878af3d12018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA74PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWPURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRPURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-014PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, LP]13Current NDC, Legacy NDC, 4 package rows20241127_e3165538-75dd-4f0f-adc8-d4075de10f1e.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750e0355-369e-b679-e053-2a91aa0a66ca2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750efd58-5845-fbc4-e053-2a91aa0a86d12023-11-01WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALGREEN COMPANYba4a29b3-2ddc-b906-e053-2995a90a2ab72023-11-01WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e98f9d9-679c-63a2-e053-2991aa0a4b8d2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e957b01-4f44-0a2a-e053-2991aa0a37a02023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e993b13-8dc8-6653-e053-2a91aa0a4c2a2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECVS3c8e4144-6702-2678-e054-00144ff88e882023-10-31WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
application number: M007
Sennosides Natural LaxativeSENNOSIDESMagno-Humphries, Inc.9d22bedb-9fca-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
application number: M007
Magnesium CitrateMAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMONMajor Pharmaceuticals088e5543-c947-af78-e063-6294a90a8bc42023-10-25WarningsExact identifier
application number: M007
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact 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 EnemaPSNe3165538-75dd-4f0f-adc8-d4075de10f1e13
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCDe3165538-75dd-4f0f-adc8-d4075de10f1e13
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSYe3165538-75dd-4f0f-adc8-d4075de10f1e13
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSYe3165538-75dd-4f0f-adc8-d4075de10f1e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-014-11533290014111 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE1 bottle2017-11-100000-00-00NoNoCurrent
53329-014-585332900145824 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE24 bottle2017-11-030000-00-00NoNoCurrent