FDA.reportPublic FDA data

Saline Laxative

Product NDC
49348-005
11-digit product format
493480005
Labeler code
49348
Product ID
49348-005_40892738-fa0d-4ab4-8609-3c4eda46be7e
Type
HUMAN OTC DRUG
Nonproprietary name
sodium phosphate
Dosage form
ENEMA
Route
RECTAL
Labeler
McKesson
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-31
Marketing end
0000-00-00
Substance
SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
Active strength
7 g/118mL; g/118mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-005-112019-11-27C16284748780-19855e2a2-41d9-60a7-e053-dbdaa90a05bdDrug Facts
49348-005-352019-11-27C16284748780-19855e2a2-41d9-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-005-11Saline Laxative133 mL in 1 BOTTLEENEMA1332
49348-005-11Saline Laxative1 in 1 BOXENEMA12
49348-005-35Saline Laxative133 mL in 1 BOTTLEENEMA1332
49348-005-35Saline Laxative2 in 1 BOXENEMA22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA74SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2
WATERINACTIVE INGREDIENT059QF0KO0RSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-005SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MCKESSON]2Legacy NDC, 4 package rows20131205_8bf5f0a6-d786-457e-bedf-e30f347b98c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN8bf5f0a6-d786-457e-bedf-e30f347b98c12
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD8bf5f0a6-d786-457e-bedf-e30f347b98c12
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY8bf5f0a6-d786-457e-bedf-e30f347b98c12
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY8bf5f0a6-d786-457e-bedf-e30f347b98c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49348-005-1149348000511133 mL in 1 BOTTLE133 mlHistorical
49348-005-3549348000535133 mL in 1 BOTTLE133 mlHistorical