FDA.reportPublic FDA data

White Tetterine

Product NDC
12258-242
11-digit product format
122580242
Labeler code
12258
Product ID
12258-242_5d425a91-4ff1-ab1b-e063-6294a90a7f13
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
S.S.S. Company
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-02-28
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct12258-242UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12258-24212258-242-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
White Tetterine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12258-242-01White Tetterine28.4 g in 1 TUBEOINTMENT28.46
12258-242-01White Tetterine1 in 1 CARTONOINTMENT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KWHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
MiconazoleACTIVE MOIETY7NNO0D7S5MWHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
aluminum starch octenylsuccinateINACTIVE INGREDIENTI9PJ0O6294WHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEWHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UWHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12258-242WHITE TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]5Current NDC, Legacy NDC, 2 package rows20250119_861895df-c989-4afd-bb31-c87c644139ef.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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998442miconazole nitrate 2 % Topical OintmentPSN861895df-c989-4afd-bb31-c87c644139ef6
998458Tetterine 2 % Topical OintmentPSN861895df-c989-4afd-bb31-c87c644139ef6
998458miconazole nitrate 0.02 MG/MG Topical Ointment [Tetterine]SBD861895df-c989-4afd-bb31-c87c644139ef6
998442miconazole nitrate 0.02 MG/MG Topical OintmentSCD861895df-c989-4afd-bb31-c87c644139ef6
998442miconazole nitrate 2 % Topical OintmentSY861895df-c989-4afd-bb31-c87c644139ef6
998458Tetterine 0.02 MG/MG Topical OintmentSY861895df-c989-4afd-bb31-c87c644139ef6
998458Tetterine 2 % Topical OintmentSY861895df-c989-4afd-bb31-c87c644139ef6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12258-242-01122580242011 TUBE in 1 CARTON (12258-242-01) / 28.4 g in 1 TUBE1 tube1995-02-280000-00-00NoNoCurrent