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
Ingredient	Strength
SODIUM PHOSPHATE, DIBASIC	7 g/118mL
SODIUM PHOSPHATE, MONOBASIC	19 g/118mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GR686LBA74	Internal UNII lookup
3980JIH2SW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e3165538-75dd-4f0f-adc8-d4075de10f1e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-014-11	Pure and Gentle Laxative	1 in 1 BOX	ENEMA	1	13
53329-014-11	Pure and Gentle Laxative	133 mL in 1 BOTTLE	ENEMA	133	13
53329-014-58	Pure and Gentle Laxative	133 mL in 1 BOTTLE	ENEMA	133	13
53329-014-58	Pure and Gentle Laxative	24 in 1 CASE	ENEMA	24	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-014-11	ML - Milliliter	53329-014	880b0529-6881-4d11-8446-2e878878af3d	1	2018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	GR686LBA74	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3
SODIUM PHOSPHATE, MONOBASIC	ACTIVE INGREDIENT	3980JIH2SW	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-014	PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, LP]	13	Current NDC, Legacy NDC, 4 package rows	20241127_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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	United Natural Foods, Inc. dba UNFI	cb7bc571-295f-47c2-ae93-18cba194752c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Strategic Sourcing Services LLC	e4965086-dcc0-4b34-bb30-81facf7139f3	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Valu Merchandisers Company	cd3e5836-b2f0-41f3-8623-3105c4642491	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Valu Merchandisers Company	a693f6b0-0679-4609-9ca0-dddfa4158c02	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Valu Merchandisers Company	fb358bc3-e479-42e7-8aea-a6a3676f2430	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Valu Merchandisers Company	ff539c1c-9ed3-49be-9b30-1858f12e1e90	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	United Natural Foods, Inc. dba UNFI	bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Walgreens SmoothLAX Soft Chews	MAGNESIUM HYDROXIDE	Walgreens	424e27ce-0b11-9cd2-e063-6294a90a3c21	2026-02-16	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	da013c15-3531-4dc5-b122-bfc99bc494ae	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	db1bc651-1a35-4f92-a917-c6a19f421594	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	The Kroger Co.	e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b	2026-02-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	b2ec06b3-647d-49ab-a392-6db63d96d1e3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Topco Associates LLC	5643f2e0-93e2-4c2e-90a0-fd152150d18a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Topco Associates LLC	d3cc7cb6-098e-413c-b1ad-7ebf5fa35269	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Topco Associates LLC	bc89c4bc-5207-479d-9a3b-e570b412a7ba	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	72f69aa0-381a-4e5c-975d-3a73fdc1b377	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Topco Associates LLC	e9b1fd61-c229-4529-82c2-d6ac5b076082	2026-02-13	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Pinnacle RX LLC	4abbb0e4-e005-bc4e-e063-6394a90a126a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
365 Whole Foods Market Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market, Inc.	4147cdd0-57f6-3857-e063-6394a90afecb	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Your Military Exchanges	27cff497-123c-424a-9c43-57740c00168b	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SE337SVY37	SODIUM PHOSPHATE	7632-05-5	sodium phosphate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283100	sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema	PSN	e3165538-75dd-4f0f-adc8-d4075de10f1e	13
283100	sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema	SCD	e3165538-75dd-4f0f-adc8-d4075de10f1e	13
283100	sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema	SY	e3165538-75dd-4f0f-adc8-d4075de10f1e	13
283100	sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema	SY	e3165538-75dd-4f0f-adc8-d4075de10f1e	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-014-11	53329001411	1 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE	1 bottle	2017-11-10	0000-00-00	No	No	Current
53329-014-58	53329001458	24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE	24 bottle	2017-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
014 Pure & Gentle Saline Enema Laxative	Medline Industries, LP	2024-11-26	HUMAN OTC DRUG LABEL	13