FDA.reportPublic FDA data

NDC 51316-991-01 - CVS Mini Enema

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51316-991
Requested NDC
51316-991-01
Package NDCs from labels
51316-991-01, 51316-991-05
Manufacturer
CVS HEALTH | Enemeez, LLC dba Summit Pharmaceuticals | Enemeez LLC DBA Summit Pharmaceuticals
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CVSHealth Ready-to-Use Mini EnemaCVS HEALTH | Enemeez, LLC dba Summit Pharmaceuticals | Enemeez LLC DBA Summit Pharmaceuticals2025-12-04HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-991-01CVS Mini Enema5 mL in 1 TUBELIQUID55
51316-991-05CVS Mini Enema5 in 1 BOXLIQUID55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-991CVS MINI ENEMA (DOCUSATE SODIUM W/BENZOCAINE) LIQUID [CVS HEALTH]4Current NDC, Legacy NDC, 2 package rows20241107_ca00c520-410a-1905-e053-2995a90a56f0.zip

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 44 of 85 · 1,692 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: U3RSY48JW5
Senna-S SoftgelSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC65a1cce7-984f-490a-bd68-fea97733a72f2025-06-24WarningsExact identifier
unii: F05Q2T2JA0
FleetBISACODYLC.B. Fleet Company, Inc.324e61eb-8f6b-48d7-85c2-b1b5642691c92025-06-23WarningsExact identifier
application number: M007
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
application number: M007
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
unii: U3RSY48JW5
De La Cruz Castor OilCASTOR OILDLC Laboratories, Inc.22fbad2e-e9fa-46ba-8617-ad79483cbe9a2025-06-13WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGTerrain Pharmaceuticals32610e42-f352-09fd-e063-6394a90abff62025-06-12WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
unii: U3RSY48JW5
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
unii: U3RSY48JW5
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
unii: U3RSY48JW5
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
unii: U3RSY48JW5
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
unii: U3RSY48JW5
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGVillage Pharma29102014-9b0e-4899-958d-83111f94a6122025-06-01WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
unii: PDC6A3C0OX
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPower Health, Products, Inc.364b558b-69b5-bfa4-e063-6294a90acd0c2025-05-29WarningsExact identifier
application number: M007

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.