FDA.reportPublic FDA data

GeriGentle Miconazole nitrate

Product NDC
69771-165
11-digit product format
697710165
Labeler code
69771
Product ID
69771-165_6ff1ce91-f486-4701-ae08-909da151b402
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
Marketing end
2028-06-30
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
GeriGentle Miconazole nitrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ae03b4a-06c8-ddf9-e063-6294a90ad105Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWalgreens Company3f8d45e1-54a2-a658-e063-6294a90a6cbb2026-06-01WarningsExact identifier
application number: M005
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)TOLNAFTATE1%Guangzhou Huixue Biotechnology Co., Ltd.52f1f654-fba3-e90e-e063-6394a90a1df42026-05-29WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
application number: M005
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL TEA TREETOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd52b3b0df-3f62-f9bc-e063-6394a90a52b32026-05-26WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsExact identifier
application number: M005
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsExact identifier
application number: M005
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
application number: M005
KDMANTOLNAFTATEDongguan Youmi Trading Co., Ltd52a4e836-2059-a49f-e063-6394a90a65562026-05-25WarningsExact identifier
application number: M005
PUTRIZENUNDECYLENIC ACID, TOLNAFTATEGuangzhou Lianbiquan Biological Technology co., Ltd52a58f24-2a11-4d34-e063-6394a90a29242026-05-25WarningsExact identifier
application number: M005
Eye CareSprayEYELID CLEANSING SPRAYShenzhen Shierjie Biological Engineering Co., LTD52aef5dd-ff33-cace-e063-6294a90a415a2026-05-25WarningsExact identifier
application number: M005
Saviland PRO Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5250003a-8d3a-818b-e063-6294a90aa6592026-05-21WarningsExact identifier
application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52506297-44d7-b2a7-e063-6394a90a0a3c2026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52512e7e-5e28-4383-e063-6294a90a448a2026-05-21WarningsExact identifier
application number: M005
Vrenmol Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52516861-e386-d0cb-e063-6394a90a17d02026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
application number: M005
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsExact identifier
application number: M005

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 startMarketing endSampleExclude flagStatus
69771-165-036977101650385 g in 1 BOTTLE, PLASTIC (69771-165-03) 85 g2022-08-192028-06-30NoNoHistorical