FDA.reportPublic FDA data

Molecular AF

Product NDC
76348-401
Requested package NDC
76348-401-02
11-digit product format
763480401
Labeler code
76348
Product ID
76348-401_2d3f2f5e-be56-71e9-e063-6294a90a6ac2
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate
Dosage form
OIL
Route
TOPICAL
Labeler
Renu Laboratories, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-01
Substance
TOLNAFTATE
Active strength
.01 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
Molecular AF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.01 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1362937Internal RxNorm lookup
1362942Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b47e687-29cf-48ce-8bc3-ac8f44f05baaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
76348-401-012025-02-04MOLECULAR AF
76348-401-022025-02-04MOLECULAR AF
76348-401-012025-01-30MOLECULAR AF
76348-401-022025-01-30MOLECULAR AF
76348-401-012023-06-13MOLECULAR AF
76348-401-022023-06-13MOLECULAR AF
76348-401-012020-01-31MOLECULAR AF
76348-401-022020-01-31MOLECULAR AF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-401-01Molecular AF11.5 mL in 1 BOTTLEOIL11.54
76348-401-02Molecular AF11.5 mL in 1 BOXOIL11.54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
TOLNAFTATEACTIVE MOIETY06KB629TKVMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
ETHYL MACADAMIATEINACTIVE INGREDIENTANA2NCS6V1MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GMOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-401MOLECULAR AF (TOLNAFTATE) OIL [RENU LABORATORIES, LLC]4Current NDC, Legacy NDC, 2 package rows20250206_1b47e687-29cf-48ce-8bc3-ac8f44f05baa.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 1 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-07-27WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
application number: M005
DERMFREE ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD49ab5abb-d311-505d-e063-6294a90a56162026-07-21WarningsExact identifier
application number: M005
DERMFREE FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD49aba00d-9249-b403-e063-6394a90a787d2026-07-21WarningsExact identifier
application number: M005
SKAPEMED SKIN REPAIRTOLNAFTATE 1% SKIN REPAIRJiangxi Yudexi Pharmaceutical Co., LTD4a20c32e-0551-aead-e063-6394a90a2aa72026-07-21WarningsExact identifier
application number: M005
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362942Molecular AF 1 % Antifungal Topical OilPSN1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362937tolnaftate 1 % Topical OilPSN1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362942tolnaftate 10 MG/ML Topical Oil [Molecular AF]SBD1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362937tolnaftate 10 MG/ML Topical OilSCD1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362942Molecular AF 1 % Topical OilSY1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362942Molecular AF 10 MG/ML Topical OilSY1b47e687-29cf-48ce-8bc3-ac8f44f05baa4
1362937tolnaftate 1 % Topical OilSY1b47e687-29cf-48ce-8bc3-ac8f44f05baa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-401-027634804010211.5 mL in 1 BOX (76348-401-02) 11.5 ml2011-07-01NoNoCurrent