Miconazorb AF

Product NDC
46122-789
11-digit product format
461220789
Labeler code
46122
Product ID
46122-789_42642785-742d-6084-e063-6294a90abf74
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
AmerisourceBergen Drug Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-05
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Miconazorb AF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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
13a20d21-42d5-fe56-e063-6394a90aaf57Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-789-29Miconazorb AF71 g in 1 BOTTLE, PLASTICPOWDER714

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-789-29GM - Gram46122-78951a0c5f9-94dc-411f-9903-7a1198f66f7312024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-789MICONAZORB AF (MICONAZOLE NITRATE) POWDER [AMERISOURCEBERGEN DRUG CORPORATION]3Current NDC, 1 package rows20241123_13a20d21-42d5-fe56-e063-6394a90aaf57.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 23 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4868de4b-65ea-01ed-e063-6294a90ae5512026-01-15WarningsExact identifier
application number: M005
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsExact identifier
application number: M005
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA483f3199-7357-112c-e063-6394a90aafa42026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA48555528-bbbc-ccef-e063-6294a90a66092026-01-14WarningsExact identifier
application number: M005
HERMON ANTIFUNGAL BARTOLNAFTATEHaikou Pucao Trading Co.,Ltd2da7a20e-021e-2111-e063-6294a90ad4412026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4866d108-0bbb-12bf-e063-6394a90a338c2026-01-14WarningsExact identifier
application number: M005
Hermon Ringworm Treatment Body WashTOLNAFTATE 1%Beautivity LLC48417be9-7cc0-e2f3-e063-6294a90aa2a22026-01-13WarningsExact identifier
application number: M005
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
application number: M005
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsExact identifier
application number: M005
Zeasorb Athletes FootMICONAZOLE NITRATECrown Laboratories09bb313e-90cb-5629-e063-6294a90ac2682026-01-12WarningsExact identifier
application number: M005
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
application number: M005
BZK Antiseptic SwabBENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.94043f4e-fe47-4b6f-8354-30697daaed812026-01-12WarningsExact identifier
application number: M005
miconazole nitrateMICONAZOLE NITRATEAvPAKeaf016f6-b631-af00-e053-2a95a90adc7b2026-01-09WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company68a4e3f5-f84d-5650-e053-2a91aa0a171d2026-01-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company79234400-0766-792c-e053-2a91aa0a6e6d2026-01-08WarningsExact identifier
application number: M005
FortiniaCLOTRIMAZOLE 1%The Podiatree Companya003130b-77f7-4d42-8e7f-edd55176f0132026-01-08WarningsExact identifier
application number: M005
Fortinia OFCLOTRIMAZOLE 1%The Podiatree Company60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f2026-01-08WarningsExact identifier
application number: M005
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
application number: M005
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN13a20d21-42d5-fe56-e063-6394a90aaf574
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD13a20d21-42d5-fe56-e063-6394a90aaf574
998461miconazole nitrate 2 % Topical PowderSY13a20d21-42d5-fe56-e063-6394a90aaf574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-789-294612207892971 g in 1 BOTTLE, PLASTIC (46122-789-29) 71 g2024-04-05NoNoCurrent