RoMMY Jean-Pierre LLC Anti-fungal Cream

Product NDC
87306-126
11-digit product format
873060126
Labeler code
87306
Product ID
87306-126_4a533c14-3fe3-9ee7-e063-6294a90a3fe6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
RoMMY Jean-Pierre LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
Substance
CAMPHOR (SYNTHETIC); MENTHOL; MICONAZOLE NITRATE; SULFUR
Active strength
1; 1; 2; 5 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoMMY Jean-Pierre LLC Anti-fungal Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)1 g/100g
MENTHOL1 g/100g
MICONAZOLE NITRATE2 g/100g
SULFUR5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, VW4H1CYW1K, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87306-126-01RoMMY Jean-Pierre LLC Anti-fungal Cream113.4 g in 1 JARCREAM113.41
87306-126-02RoMMY Jean-Pierre LLC Anti-fungal Cream56.7 g in 1 JARCREAM56.71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87306-126-0187306012601113.4 g in 1 JAR (87306-126-01) 113.4 g2026-02-08NoNoHistorical
87306-126-028730601260256.7 g in 1 JAR (87306-126-02) 56.7 g2026-02-08NoNoHistorical