FDA.reportPublic FDA data

NDC 71399-0071-01 - MICONAZOLE Nitrate 2%

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71399-0071
Requested NDC
71399-0071-01
Package NDCs from labels
71399-0071-1, 71399-0071-3, 71399-0071-4, 71399-0071-01
Manufacturer
Akron Pharma Inc.
Effective date
2025-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MICONAZOLE Nitrate 2% - Akron Pharma Inc.Akron Pharma Inc.2025-01-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0071-1MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12
71399-0071-1MICONAZOLE Nitrate 2%14.2 g in 1 TUBECREAM14.22
71399-0071-3MICONAZOLE Nitrate 2%28.4 g in 1 TUBECREAM28.42
71399-0071-3MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12
71399-0071-4MICONAZOLE Nitrate 2%42.5 g in 1 TUBECREAM42.52
71399-0071-4MICONAZOLE Nitrate 2%1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0071MICONAZOLE NITRATE 2% (MICONAZOLE NITRATE) CREAM [AKRON PHARMA INC.]2Current NDC, 6 package rows20250120_8933f939-098a-4257-8d9c-4d5c3240e9a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0071-1GM - Gram71399-00711814945a-3df2-46fa-bf9c-cbf86c6023e212025-01-14
71399-0071-3GM - Gram71399-007162478811-bd3d-44d6-85d5-4aa695061e7312025-01-14
71399-0071-4GM - Gram71399-00719d8f2a9f-65b3-4c93-ba71-0fca2ff1be8a12025-01-14

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 1 of 101 · 2,018 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FGPER ANTIFUNGALMICONAZOLE NITRATEGuangzhou ChuanMa International Trading Co.,Ltd.5ced6af9-f9c4-6e62-e063-6294a90a0e112026-10-03WarningsExact identifier
application number: M005
unii: VW4H1CYW1K
Antifungal LiquidTOLNAFTATETarget Corporation3c6dd772-0d26-b659-e063-6294a90a5bf82026-09-24WarningsExact identifier
application number: M005
Pharmacys Prescription 4.5 OZ Creamy Petroleum JellyWHITE PETROLATUMAmerican Consumer Products Corp.5c3eb6b1-d570-0b4c-e063-6394a90af4622026-09-24WarningsExact identifier
unii: 4T6H12BN9U
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
rxcui: 998483
unii: VW4H1CYW1K
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
rxcui: 998483
unii: VW4H1CYW1K
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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