FDA.reportPublic FDA data

Green Tetterine

Product NDC
12258-241
11-digit product format
122580241
Labeler code
12258
Product ID
12258-241_5d424d20-fe08-974f-e063-6294a90a78de
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
1994-07-31
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 productproduct12258-241UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12258-24112258-241-01UExcluded 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
Green 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
12258-241-01Green Tetterine28.4 g in 1 CANOINTMENT28.46
12258-241-01Green Tetterine1 in 1 CARTONOINTMENT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KGREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
MiconazoleACTIVE MOIETY7NNO0D7S5MGREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
aluminum starch octenylsuccinateINACTIVE INGREDIENTI9PJ0O6294GREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
fd&c blue no. 1INACTIVE INGREDIENTH3R47K3TBDGREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEGREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UGREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12258-241GREEN TETTERINE (MICONAZOLE NITRATE) OINTMENT [S.S.S. COMPANY]5Current NDC, Legacy NDC, 2 package rows20250119_4de96ed4-7506-4acd-8e8d-ea74bfd18e4a.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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
Micotrin ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
application number: M005
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsExact identifier
application number: M005
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
application number: M005
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
application number: M005
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
application number: M005
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
application number: M005
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M005
Mentholatum Heel Revival CreamMENTHOLATUM HEEL REVIVAL CREAMThe Mentholatum Company21b643c2-eb6e-8939-e063-6394a90aaeac2024-09-09WarningsExact identifier
application number: M005
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Tropical Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.3645359c-06a2-4b97-b982-c54e4a0b8cda2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Coastal Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.645c09dc-15a4-481f-a605-f12fb8f8e9bd2024-09-04WarningsExact identifier
application number: M005
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
application number: M005
ANTIFUNGAL FOOTTOLNAFTATEUniversal Distribution Center LLC10579848-5793-4d72-ad5f-62d191c710742024-07-16WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998442miconazole nitrate 2 % Topical OintmentPSN4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998458Tetterine 2 % Topical OintmentPSN4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998458miconazole nitrate 0.02 MG/MG Topical Ointment [Tetterine]SBD4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998442miconazole nitrate 0.02 MG/MG Topical OintmentSCD4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998442miconazole nitrate 2 % Topical OintmentSY4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998458Tetterine 0.02 MG/MG Topical OintmentSY4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6
998458Tetterine 2 % Topical OintmentSY4de96ed4-7506-4acd-8e8d-ea74bfd18e4a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12258-241-01122580241011 CAN in 1 CARTON (12258-241-01) / 28.4 g in 1 CAN1 can1994-07-310000-00-00NoNoCurrent