Beilloso Balanitis Relief

Product NDC
85248-138
11-digit product format
852480138
Labeler code
85248
Product ID
85248-138_4a71c26f-dee6-7b7f-e063-6294a90afcc1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate 2% Balanitis Relief
Dosage form
CREAM
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-10
Substance
MICONAZOLE NITRATE
Active strength
2 g/100mL
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
Beilloso Balanitis Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-138-01Beilloso Balanitis Relief30 mL in 1 BOTTLECREAM301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN4a71c26f-dee5-7b7f-e063-6294a90afcc11
998483miconazole nitrate 20 MG/ML Topical CreamSCD4a71c26f-dee5-7b7f-e063-6294a90afcc11
998483miconazole nitrate 2 % Topical CreamSY4a71c26f-dee5-7b7f-e063-6294a90afcc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-138-018524801380130 mL in 1 BOTTLE (85248-138-01) 30 ml2026-02-10NoNoHistorical