MetroLotion

Product NDC
0299-3838
11-digit product format
002993838
Labeler code
0299
Product ID
0299-3838_986498be-52fe-47ba-a639-5267a03e98bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA020901
Marketing category
NDA
Marketing start
1998-11-24
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
8 mg/mL
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-3838-02ML - Milliliter0299-3838c4801c5d-bf5b-42c4-94fd-b2119c13a96a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MetronidazoleACTIVE INGREDIENT140QMO216EMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
MetronidazoleACTIVE MOIETY140QMO216EMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Carbomer Homopolymer Type AINACTIVE INGREDIENTF68VH75CJCMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
CyclomethiconeINACTIVE INGREDIENTNMQ347994ZMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Lactic AcidINACTIVE INGREDIENT33X04XA5ATMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999RMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ4METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Steareth-21INACTIVE INGREDIENT53J3F32P58METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1
WaterINACTIVE INGREDIENT059QF0KO0RMETROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-3838METROLOTION (METRONIDAZOLE) LOTION [GALDERMA LABORATORIES, L.P.]3Legacy NDC20180706_c4e07c26-245d-3e51-6a47-fccde22334d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0299-3838-02002993838021 BOTTLE, PLASTIC in 1 CARTON (0299-3838-02) > 59 mL in 1 BOTTLE, PLASTIC1998-11-240000-00-00NoNoCurrent