FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
4718 Enema, Mineral Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL133 g/133mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP
Rxcui205121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-430-014718 Enema, Mineral Oil48 in 1 CASEENEMA483
67777-430-024718 Enema, Mineral Oil133 mL in 1 BOTTLEENEMA1333
67777-430-024718 Enema, Mineral Oil1 in 1 BOXENEMA13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-4304718 ENEMA, MINERAL OIL ENEMA [DYNAREX]3Current NDC, Legacy NDC, 3 package rows20241122_9e51c852-9477-5cf5-e053-2a95a90a97db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205121mineral oil 100 % EnemaPSN9e51c852-9477-5cf5-e053-2a95a90a97db3
205121mineral oil 1000 MG/ML EnemaSCD9e51c852-9477-5cf5-e053-2a95a90a97db3
205121mineral oil 100 % EnemaSY9e51c852-9477-5cf5-e053-2a95a90a97db3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-430-016777704300148 BOX in 1 CASE (67777-430-01) / 1 BOTTLE in 1 BOX (67777-430-02) / 133 mL in 1 BOTTLE48 box2021-02-260000-00-00NoNoCurrent
67777-430-0267777043002133 mL in 1 BOTTLE133 mlHistorical