FDA.reportPublic FDA data

Tolnaftate

Product NDC
11822-0782
11-digit product format
118220782
Labeler code
11822
Product ID
11822-0782_38107f11-b1bf-fa22-e063-6394a90a2eac
Type
HUMAN OTC DRUG
Nonproprietary name
Jock Itch Powder
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-15
Marketing end
2028-03-31
Substance
TOLNAFTATE
Active strength
1.3 g/130g
NDC exclude flag
No
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
Tolnaftate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1.3 g/130g

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
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6968587-45c2-d2f8-e053-2a95a90a8401Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0782-42023-01-31C16284748780-1f386c649-dbf9-0266-e053-dadaa90a7c1aRite Aid Antifungal Jock Itch Powder Spray Tolnaftate 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0782-4Tolnaftate130 g in 1 CANAEROSOL, SPRAY1306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0782TOLNAFTATE (JOCK ITCH POWDER) AEROSOL, SPRAY [RITE AID CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241213_b6968587-45c2-d2f8-e053-2a95a90a8401.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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSNb6968587-45c2-d2f8-e053-2a95a90a84016
705934tolnaftate 0.01 MG/MG Powder SpraySCDb6968587-45c2-d2f8-e053-2a95a90a84016
705934tolnaftate 1 % Powder SpraySYb6968587-45c2-d2f8-e053-2a95a90a84016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0782-411822078204130 g in 1 CAN (11822-0782-4) 130 g2021-03-152028-03-31NoNoCurrent