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 13 of 86 · 1,709 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
unii: U3RSY48JW5
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack2c0d62e7-563b-46e4-9793-183e98e761a62026-03-25WarningsExact identifier
application number: M007
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGGrocery Outletc820e6a1-fa23-447a-9ee9-50a1bd617adb2026-03-19WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLC9d5f2244-a610-4d45-b6e8-e79bb17a558f2026-03-18WarningsExact identifier
application number: M007
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
unii: U3RSY48JW5
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
unii: U3RSY48JW5
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.f178b31d-4843-4b91-a0d5-ab5ade835dc22026-03-16WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
application number: M007
unii: F05Q2T2JA0
Castor OilCASTOR OILOld East Main Co.a1ca668a-3bf9-46a9-8a4f-5cb61547bb812026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
unii: U3RSY48JW5
Castor OilCASTOR OILVi-Jon, LLCb29775df-8470-4fe3-bee3-f0490ea6903f2026-03-12WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCcc43d514-ee82-4314-99b2-c64380f987792026-03-12Warnings, Adverse reactionsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
application number: M007

Reported adverse events (FAERS/openFDA)#

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