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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact 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