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

Additional Listing Data#

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

Field, Values table
Field	Values
Unii	GR686LBA74, 3980JIH2SW
Rxcui	283100

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

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

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

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

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

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

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

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