FDA.reportPublic FDA data

NP Enema Non Penetrating Safety Tip Saline

Product NDC
85931-018
11-digit product format
859310018
Labeler code
85931
Product ID
85931-018_5c498b3f-8cdd-d900-e063-6294a90a5e4c
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
Dosage form
LIQUID
Route
RECTAL
Labeler
Sterilab, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-15
Substance
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
Active strength
19; 7 g/mL; g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
NP Enema Non Penetrating Safety Tip Saline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g/mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g/mL

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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inccc97cfb5-cd40-4589-942a-5bee611a28122026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inc0ac1896d-7ed9-44e5-bf07-1478262372732026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILChain Drug Marketing Association4a003bb1-425d-cd97-e063-6294a90a5dda2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLCd8176ef6-cc68-4185-b5eb-e887562f6aaa2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLC07732845-c9ce-47bb-8b63-36a3d5ddf8b72026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
stimulant laxativeBISACODYLBIONPHARMA INC.4b1f7db3-c6a8-7f6a-e063-6394a90a58292026-02-22WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCff6c8022-9522-4eae-b8ff-994ee37fba062026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILPerrigo Direct, Inc09e32476-1c60-4f1e-a51c-5fab2e744b302026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc22991685-8228-41e1-a13e-f57961e8dd0e2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc24478279-9a11-4e12-956d-57dc7debf9412026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILMeijer, Inc.c4d03837-193b-4817-8b78-fbdfb9122f192026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATETarget Corporationa8e52a22-7c30-40c0-8f78-523775743bfb2026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85931-018-00859310018001 BOTTLE, WITH APPLICATOR in 1 BOX (85931-018-00) / 133 mL in 1 BOTTLE, WITH APPLICATOR2026-09-15NoNoCurrent