GeriGentle Miconazole nitrate

Product NDC
69771-165
11-digit product format
697710165
Labeler code
69771
Product ID
69771-165_422963ab-509d-6688-e063-6394a90af529
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal
Dosage form
POWDER
Route
TOPICAL
Labeler
GERI-GENTLE CORPORATION
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-19
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GeriGentle Miconazole nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-165-03GeriGentle Miconazole nitrate85 g in 1 BOTTLE, PLASTICPOWDER854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-165GERIGENTLE MICONAZOLE NITRATE (ANTIFUNGAL) POWDER [GERI-GENTLE CORPORATION]2Current NDC, 1 package rows20240627_0ae03b4a-06c8-ddf9-e063-6294a90ad105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN0ae03b4a-06c8-ddf9-e063-6294a90ad1054
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD0ae03b4a-06c8-ddf9-e063-6294a90ad1054
998461miconazole nitrate 2 % Topical PowderSY0ae03b4a-06c8-ddf9-e063-6294a90ad1054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69771-165-036977101650385 g in 1 BOTTLE, PLASTIC (69771-165-03) 85 g2022-08-19NoNoHistorical