4718 Enema, Mineral Oil

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: 4718 Enema, Mineral Oil
Generic name: 4718 ENEMA, MINERAL OIL
Manufacturer: Dynarex
Product type: HUMAN OTC DRUG
SPL set ID: 9e51c852-9477-5cf5-e053-2a95a90a97db
SPL ID: 27596c71-a1ec-2f3c-e063-6394a90a8d6d
Version: 3
Effective date: 2024-11-20
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:24:32

Harmonized routes table
Harmonized routes
RECTAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007	openfda.application_number
brand name		4718 Enema, Mineral Oil	openfda.brand_name
generic name		4718 ENEMA, MINERAL OIL	openfda.generic_name
manufacturer name		Dynarex	openfda.manufacturer_name
ndc	package	67777-430-02	openfda.package_ndc
ndc	package	67777-430-01	openfda.package_ndc
ndc	product	67777-430	openfda.product_ndc
ndc11	package	67777043002	derived:openfda.package_ndc
ndc11	package	67777043001	derived:openfda.package_ndc
rxcui		205121	openfda.rxcui
spl id		27596c71-a1ec-2f3c-e063-6394a90a8d6d	id
spl set id		9e51c852-9477-5cf5-e053-2a95a90a97db	set_id
unii		T5L8T28FGP	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For rectal use only. Do not use Laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor. Longer than one week unless directed by a doctor. Ask a doctor before use if you have Noticed a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if You have rectal bleeding or fail to have a bowel movement after use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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