NDC 67777-401

Enema

Mineral Oil

Enema is a Rectal Enema in the Human Otc Drug category. It is labeled and distributed by Dynarex Corporation. The primary component is Mineral Oil.

Product ID67777-401_70550386-0a48-4cd4-84c9-fc9b6e1bfc61
NDC67777-401
Product TypeHuman Otc Drug
Proprietary NameEnema
Generic NameMineral Oil
Dosage FormEnema
Route of AdministrationRECTAL
Marketing Start Date2012-08-29
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameDynarex Corporation
Substance NameMINERAL OIL
Active Ingredient Strength1 mL/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 67777-401-01

118 mL in 1 BOTTLE (67777-401-01)
Marketing Start Date2012-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67777-401-01 [67777040101]

Enema ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-08-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL1 mL/mL

OpenFDA Data

SPL SET ID:141ff82f-ba4c-4646-8544-2350d4f85563
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205121
    • UPC Code
  • 0616784471815

    • NDC Crossover Matching brand name "Enema" or generic name "Mineral Oil"

    NDCBrand NameGeneric Name
    67777-401EnemaEnema
    0132-0119FleetEnema
    0132-0301FLEETMineral Oil
    0132-0556FLEETMineral Oil
    0395-1685Humco Mineral Oil HeavyMineral Oil
    0395-1673Humco Mineral Oil LightMineral Oil
    0363-0360Mineral OilMineral Oil
    0363-0831Mineral OilMineral Oil
    0363-0834Mineral OilMineral Oil
    0574-0618Mineral OilMineral Oil
    11673-034Mineral oilMineral oil
    11673-831Mineral OilMineral Oil
    11822-0603Mineral OilMineral Oil
    11822-3340Mineral OilMineral Oil
    11822-3601Mineral OilMineral Oil
    15127-334Mineral oilMineral oil
    15127-831Mineral OilMineral Oil
    0395-9135Mineral Oil HeavyMineral Oil
    0363-0006Mineral Oil Lubricant Laxativemineral oil
    0869-0831oilMineral Oil
    0363-8831Walgreens Lubricant Eye Drops Preservative FreeMineral Oil
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.