FDA.reportPublic FDA data

Rapid MicroGel

Product NDC
49406-005
11-digit product format
494060005
Labeler code
49406
Product ID
49406-005_3cbd0337-1037-1a59-e063-6294a90a7d97
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
GEL
Route
TOPICAL
Labeler
The Tetra Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-13
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49406-00549406-005-30DDiscontinued by firm2026-10-12

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49406-00549406-005-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49406-00549406-005-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Rapid MicroGel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313420Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
afb6d7c4-1f75-4694-83c8-d6469250d6a1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49406-005-28Rapid MicroGel28 g in 1 JARGEL282
49406-005-30Rapid MicroGel15 g in 1 PACKAGEGEL152

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 14 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.51465ebf-3b5f-e2bf-e063-6394a90adaf22026-05-07WarningsExact identifier
application number: M005
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
application number: M005
QQE Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.510ff705-e2cb-b77b-e063-6394a90a9e722026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
application number: M005
NATURAL CURES FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD510a8df7-ea6d-d634-e063-6294a90aea532026-05-04WarningsExact identifier
application number: M005
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
application number: M005
Uauko Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.50d16854-ab90-d6cf-e063-6294a90a21b12026-05-02WarningsExact identifier
application number: M005
NAIL RENEWTOLNAFTATENailrenew Corpa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b52026-05-02WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZER SPRAYCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4934c20d-6295-aeb8-e063-6394a90adfeb2026-04-30WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4931f2e4-0fef-a8c7-e063-6394a90ac16e2026-04-30WarningsExact identifier
application number: M005
MINADCIN TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD50a9264e-aba0-0ae2-e063-6294a90acfff2026-04-30WarningsExact identifier
application number: M005
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.493120ee-0c5c-b704-e063-6394a90a8c192026-04-29WarningsExact identifier
application number: M005
ProBliva Antifungal Scrub .soap. BarTOLNAFTATE 1%CAVTECH HOLDING LLC5090a9ad-3df7-6699-e063-6394a90a72f72026-04-28WarningsExact identifier
application number: M005
FifthPulse Clotrimazole AntifungalCLOTRIMAZOLEWeCare Products LLC9f5ea297-5a25-42cc-bd47-4159108b00232026-04-27WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PENJiangxi Yudexi Pharmaceutical Co., LTD501cf54a-31da-6db2-e063-6394a90a65f82026-04-23WarningsExact identifier
application number: M005
Medicated Athletes Foot PowderMICONAZOLE NITRATEPremier Brands of America Inc.38cc0c66-82b5-bac4-e063-6294a90a23f02026-04-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313420tolnaftate 1 % Topical GelPSNafb6d7c4-1f75-4694-83c8-d6469250d6a12
313420tolnaftate 0.01 MG/MG Topical GelSCDafb6d7c4-1f75-4694-83c8-d6469250d6a12
313420tolnaftate 1 % Topical GelSYafb6d7c4-1f75-4694-83c8-d6469250d6a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49406-005-284940600052828 g in 1 JAR (49406-005-28) 28 g2020-01-28NoNoCurrent
49406-005-304940600053015 g in 1 PACKAGE15 gHistorical