FDA.reportPublic FDA data

Dynarex Antifungal

Product NDC
67777-231
11-digit product format
677770231
Labeler code
67777
Product ID
67777-231_2758be66-4129-317b-e063-6394a90a712a
Type
HUMAN OTC DRUG
Nonproprietary name
antifungal
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-18
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
Dynarex Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab5b6467-c158-4407-9d52-3c0731030680Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-231-01Dynarex Antifungal113 g in 1 TUBECREAM1139
67777-231-02Dynarex Antifungal28.25 g in 1 TUBECREAM28.259
67777-231-10Dynarex Antifungal6 in 1 BOXCREAM69
67777-231-11Dynarex Antifungal24 in 1 CASECREAM249
67777-231-12Dynarex Antifungal1 in 1 BOXCREAM19
67777-231-13Dynarex Antifungal72 in 1 CASECREAM729

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-231-01GM - Gram67777-23199921f3b-4443-41a1-9130-1db4ff8c63d612022-06-06
67777-231-02GM - Gram67777-231f9a088f1-92fd-4f38-a0e8-8797bd4b040912025-03-04
67777-231-10GM - Gram67777-23181f56843-c25e-42cb-b232-b89600da618712023-08-08
67777-231-11GM - Gram67777-231a447aa5f-5434-437f-b736-2eaedcfae57712023-08-08
67777-231-12GM - Gram67777-2316b98979a-4395-40ca-8d6c-edae41686aee12023-08-08
67777-231-13GM - Gram67777-2310ec8384b-b984-41c0-b715-983e0ade53e112023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65DYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65DYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
CETETH-20INACTIVE INGREDIENTI835H2IHHXDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RDYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-231DYNAREX ANTIFUNGAL (ANTIFUNGAL) CREAM [DYNAREX CORPORATION]9Current NDC, Legacy NDC, 6 package rows20241122_ab5b6467-c158-4407-9d52-3c0731030680.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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNab5b6467-c158-4407-9d52-3c07310306809
309367clotrimazole 10 MG/ML Topical CreamSCDab5b6467-c158-4407-9d52-3c07310306809
309367clotrimazole 1 % Topical CreamSYab5b6467-c158-4407-9d52-3c07310306809

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-231-0167777023101113 g in 1 TUBE (67777-231-01) 113 g2010-05-190000-00-00NoNoCurrent
67777-231-026777702310228.25 g in 1 TUBE (67777-231-02) 28.25 g2010-05-190000-00-00NoNoCurrent
67777-231-10677770231106 in 1 BOXHistorical
67777-231-116777702311124 BOX in 1 CASE (67777-231-11) / 6 TUBE in 1 BOX (67777-231-10) / 113 g in 1 TUBE (67777-231-01) 24 box2010-05-180000-00-00NoNoCurrent
67777-231-12677770231121 in 1 BOXHistorical
67777-231-136777702311372 BOX in 1 CASE (67777-231-13) / 1 TUBE in 1 BOX (67777-231-12) / 28.25 g in 1 TUBE (67777-231-02) 72 box2010-05-180000-00-00NoNoCurrent