Home NDC 67777-430 4718 Enema, Mineral Oil
Product NDC 67777-430
11-digit product format 677770430
Labeler code 67777
Product ID 67777-430_27596c71-a1ec-2f3c-e063-6394a90a8d6d
Type HUMAN OTC DRUG
Nonproprietary name 4718 Enema, Mineral Oil
Dosage form ENEMA
Route RECTAL
Labeler Dynarex
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-26
Substance MINERAL OIL
Active strength 133 g/133mL
NDC exclude flag No
Listing certified through 2026-12-31
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 4718 Enema, Mineral Oil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 133 g/133mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205121 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67777-430-01 4718 Enema, Mineral Oil 48 in 1 CASE ENEMA 48 3 67777-430-02 4718 Enema, Mineral Oil 133 mL in 1 BOTTLE ENEMA 133 3 67777-430-02 4718 Enema, Mineral Oil 1 in 1 BOX ENEMA 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67777-430 4718 ENEMA, MINERAL OIL ENEMA [DYNAREX] 3 Current NDC, Legacy NDC, 3 package rows 20241122_9e51c852-9477-5cf5-e053-2a95a90a97db.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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67777-430-01 67777043001 48 BOX in 1 CASE (67777-430-01) / 1 BOTTLE in 1 BOX (67777-430-02) / 133 mL in 1 BOTTLE 48 box 2021-02-26 0000-00-00 No No Current 67777-430-02 67777043002 133 mL in 1 BOTTLE 133 ml Historical