FDA.reportPublic FDA data

Family Wellness Athletes Foot Tolnaftate 1 Cream

Product NDC
55319-991
11-digit product format
553190991
Labeler code
55319
Product ID
55319-991_2ef25f71-76b2-a7ef-e063-6294a90a48b4
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
TOLNAFTATE
Active strength
10 mg/g
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-991-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-991-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-991-000efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Family Wellness Athletes Foot Tolnaftate 1 Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

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
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f72b5bcd-8834-4da9-aa74-78992ec2838fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-991-002025-02-07C16284748780-12cef2736-6246-d83d-e063-dadaa90ab31fFamily Wellness Athletes Foot Tolnaftate 1% Cream
55319-991-002025-01-30C16284748780-12cef2736-6246-d83d-e063-dadaa90ab31fFamily Wellness Athletes Foot Tolnaftate 1% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-991-00Family Wellness Athletes Foot Tolnaftate 1 Cream14 g in 1 TUBECREAM143
55319-991-00Family Wellness Athletes Foot Tolnaftate 1 Cream1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-991FAMILY WELLNESS ATHLETES FOOT TOLNAFTATE 1 CREAM (TOLNAFTATE) CREAM [FAMILY DOLLAR STORES, INC]3Current NDC, 2 package rows20250226_f72b5bcd-8834-4da9-aa74-78992ec2838f.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 52 · 1,022 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
application number: M005
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsExact identifier
application number: M005
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-21WarningsExact identifier
application number: M005
GPPEE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.598d05bc-459d-71cf-e063-6394a90a19322026-08-21WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
application number: M005
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
application number: M005
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
application number: M005
BYT BANGYTONG FOLLICULITIS5% BENZOYL PEROXIDE FOLLICULITISShenzhen Jindali Technology Co., Ltd595363f9-6aee-93a5-e063-6394a90a0f0e2026-08-18WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEShield Line LLC9ddb13cd-34ed-2d63-e053-2a95a90ad9da2026-08-18WarningsExact identifier
application number: M005
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESTOLNAFTATEYunqi Cosmetics (Shenzhen) Co., Ltd5939c492-6481-ddae-e063-6294a90a40bb2026-08-17WarningsExact identifier
application number: M005
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNf72b5bcd-8834-4da9-aa74-78992ec2838f3
103951tolnaftate 10 MG/ML Topical CreamSCDf72b5bcd-8834-4da9-aa74-78992ec2838f3
103951tolnaftate 1 % Topical CreamSYf72b5bcd-8834-4da9-aa74-78992ec2838f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-991-00553190991001 TUBE in 1 BOX (55319-991-00) / 14 g in 1 TUBE1 tube2024-01-01NoNoCurrent