FDA.reportPublic FDA data

Saline Laxative

Product NDC
41163-005
11-digit product format
411630005
Labeler code
41163
Product ID
41163-005_771db722-84f3-4d89-aa17-9dd918e36edc
Type
HUMAN OTC DRUG
Nonproprietary name
sodium phosphate
Dosage form
ENEMA
Route
RECTAL
Labeler
Supervalu Inc
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-31
Marketing end
0000-00-00
Substance
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength
7 g/118mL; g/118mL
NDC exclude flag
No
Listing certified through
2020-12-31
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
41163-005-112025-01-30C16284748780-12cef2736-71ce-d83d-e063-dadaa90ab31fSaline Laxative
41163-005-352025-01-30C16284748780-12cef2736-71ce-d83d-e063-dadaa90ab31fSaline Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-005-11Saline Laxative133 mL in 1 BOTTLEENEMA1335
41163-005-11Saline Laxative1 in 1 BOXENEMA15
41163-005-35Saline Laxative133 mL in 1 BOTTLEENEMA1335
41163-005-35Saline Laxative2 in 1 BOXENEMA25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-005-11ML - Milliliter41163-005202b885f-381b-4041-ba0e-16c1ad3d7b7512020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA74SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4
WATERINACTIVE INGREDIENT059QF0KO0RSALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-005SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [SUPERVALU INC]5Legacy NDC, 4 package rows20190123_344100dc-0c83-4c3e-aaa6-dfd6398a20df.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 EnemaPSN344100dc-0c83-4c3e-aaa6-dfd6398a20df5
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD344100dc-0c83-4c3e-aaa6-dfd6398a20df5
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY344100dc-0c83-4c3e-aaa6-dfd6398a20df5
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY344100dc-0c83-4c3e-aaa6-dfd6398a20df5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-005-11411630005111 BOTTLE in 1 BOX (41163-005-11) > 133 mL in 1 BOTTLE1 bottle2012-08-310000-00-00NoNoCurrent
41163-005-35411630005352 BOTTLE in 1 BOX (41163-005-35) > 133 mL in 1 BOTTLE2 bottle2012-08-310000-00-00NoNoCurrent