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
Ingredient	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g/133mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	19 g/133mL

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
b3758ffe-1bac-4df6-9714-5e33e9d28d90	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	Strength	SPL version
0904-6320-78	Saline Laxative	133 mL in 1 BOTTLE	ENEMA	133		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6320-78	ML - Milliliter	0904-6320	3de6133e-b46b-4d03-a490-34409f8904b4	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	GR686LBA74	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5
SODIUM PHOSPHATE, MONOBASIC	ACTIVE INGREDIENT	3980JIH2SW	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6320	SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 1 package rows	20250101_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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stratuscare Glycerin Laxative Pediatric	GLYCERIN	Stratus Pharmaceuticals	6ae6d3c4-bb3b-4436-b76d-8654bf871e66	2024-11-01	Warnings	Exact identifier application number: M007
Rite Aid Fiber Therapy	METHYLCELLULOSE	RITE AID CORPORATION	e50cea80-c020-4b85-b61f-d053f11f479b	2024-10-30	Warnings	Exact identifier application number: M007
Rite Aid Fiber Caplets	CALCIUM POLYCARBOPHIL	RITE AID CORPORATION	06e46cb0-2928-479e-984d-2305fff995e0	2024-10-30	Warnings	Exact identifier application number: M007
Premier Value Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	2d580965-2bef-46ee-8532-fbe34330a4b4	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy	METHYLCELLULOSE	PHARMACY VALUE ALLIANCE, LLC	b875d5f8-02f3-4474-9fda-83091bc7de04	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Original Coarse	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	8c85a13d-ae99-4599-9a28-c3965caa6376	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value	CALCIUM POLYCARBOPHIL	PHARMACY VALUE ALLIANCE, LLC	4d766548-00d0-41bd-bb58-b69e037c77e2	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber	PSYLLIUM HUSK	Chain Drug Consortium, LLC	c507fe4a-1f8e-4780-a2f5-9da6e5922bef	2024-10-28	Warnings	Exact identifier application number: M007
Premier Value Fiber Therapy Orange Flavor	PSYLLIUM HUSK	PHARMACY VALUE ALLIANCE, LLC	85651bd7-e959-4455-a5ed-bd0223ce0563	2024-10-28	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c61c71-9a23-4bd3-e053-2a95a90ad460	2024-10-26	Warnings	Exact identifier application number: M007
Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	ae367381-7146-4307-823d-2bb44c1d4200	2024-10-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	f7309f4a-f1f5-420e-bfc7-fb4495a5afba	2024-10-24	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	2540ae39-2218-0f6a-e063-6294a90a5efc	2024-10-24	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM	DOCUSATE SODIUM	Sam's West Inc	b0e99ebb-41fc-459f-86d2-f0e3527f97b0	2024-10-24	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	A-S Medication Solutions	ef05ad45-7082-43e6-9533-a79c5aa0f373	2024-10-22	Warnings	Exact identifier application number: M007
Bliss GVS Children	GLYCERIN	Bliss GVS Pharma Limited	03237ed2-265f-4acd-b504-d82b9263287c	2024-10-17	Warnings	Exact identifier application number: M007
NATURAL Epsom Salt	MAGNESIUM SULFATE	Universal Distribution Center LLC	b2682e51-ffa4-4556-b2a6-b0dbd543fd4f	2024-10-16	Warnings	Exact identifier application number: M007
Bliss GVS	GLYCERIN	Bliss GVS Pharma Limited	1a3982a1-9ce9-4a1a-ba73-ebe2d8647109	2024-10-10	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	Padagis US LLC	7eada0fc-5f83-43da-a56f-b0f537298208	2024-10-10	Warnings	Exact identifier application number: M007
exchange select stool softener	DOCUSATE SODIUM	Army & Air Force Exchange Service	14985848-d791-42b9-ad7e-810a85bb1ee1	2024-10-07	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GR686LBA74	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	10140-65-5	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
3980JIH2SW	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM		SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

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	b3758ffe-1bac-4df6-9714-5e33e9d28d90	9
283100	sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema	SCD	b3758ffe-1bac-4df6-9714-5e33e9d28d90	9
283100	sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema	SY	b3758ffe-1bac-4df6-9714-5e33e9d28d90	9
283100	sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema	SY	b3758ffe-1bac-4df6-9714-5e33e9d28d90	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6320-78	00904632078	133 mL in 1 BOTTLE (0904-6320-78)	133 ml	2013-07-11	2027-04-30	No	No	Current