Family Wellness Clotrimazole 1 Anti Fungal Cream

Product NDC
55319-980
11-digit product format
553190980
Labeler code
55319
Product ID
55319-980_2ef25a3a-88ac-a05e-e063-6294a90ae1ac
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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 packagepackage55319-980-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-980-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-980-000efc9e666f02…f202fb6c5f17…

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
Family Wellness Clotrimazole 1 Anti Fungal Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

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
0667dd81-5633-494e-857e-45fa276fe72cAvailable 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-980-00Family Wellness Clotrimazole 1 Anti Fungal Cream1 in 1 BOXCREAM12
55319-980-00Family Wellness Clotrimazole 1 Anti Fungal Cream14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-980FAMILY WELLNESS CLOTRIMAZOLE 1 ANTI FUNGAL CREAM (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR STORES, INC]2Current NDC, 2 package rows20250226_0667dd81-5633-494e-857e-45fa276fe72c.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 23 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer HealthCare LLC.1300d84f-d7ff-ec57-e063-6294a90ae0de2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4868de4b-65ea-01ed-e063-6294a90ae5512026-01-15WarningsExact identifier
application number: M005
Antifungal Ringworm TreatmentMICONAZOLE NITRATERida LLCeb953281-cf86-44cf-a3d1-37b8d344a6bc2026-01-15WarningsExact identifier
application number: M005
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA483f3199-7357-112c-e063-6394a90aafa42026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA48555528-bbbc-ccef-e063-6294a90a66092026-01-14WarningsExact identifier
application number: M005
HERMON ANTIFUNGAL BARTOLNAFTATEHaikou Pucao Trading Co.,Ltd2da7a20e-021e-2111-e063-6294a90ad4412026-01-14WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4866d108-0bbb-12bf-e063-6394a90a338c2026-01-14WarningsExact identifier
application number: M005
Hermon Ringworm Treatment Body WashTOLNAFTATE 1%Beautivity LLC48417be9-7cc0-e2f3-e063-6294a90aa2a22026-01-13WarningsExact identifier
application number: M005
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
application number: M005
Zeasorb Jock ItchMICONAZOLE NITRATECrown Laboratories09d088ef-aab3-5565-e063-6394a90af2632026-01-12WarningsExact identifier
application number: M005
Zeasorb Athletes FootMICONAZOLE NITRATECrown Laboratories09bb313e-90cb-5629-e063-6294a90ac2682026-01-12WarningsExact identifier
application number: M005
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
application number: M005
BZK Antiseptic SwabBENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.94043f4e-fe47-4b6f-8354-30697daaed812026-01-12WarningsExact identifier
application number: M005
miconazole nitrateMICONAZOLE NITRATEAvPAKeaf016f6-b631-af00-e053-2a95a90adc7b2026-01-09WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company68a4e3f5-f84d-5650-e053-2a91aa0a171d2026-01-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEThe Podiatree Company79234400-0766-792c-e053-2a91aa0a6e6d2026-01-08WarningsExact identifier
application number: M005
FortiniaCLOTRIMAZOLE 1%The Podiatree Companya003130b-77f7-4d42-8e7f-edd55176f0132026-01-08WarningsExact identifier
application number: M005
Fortinia OFCLOTRIMAZOLE 1%The Podiatree Company60cbd3aa-9ad7-24e4-e053-2a91aa0ab05f2026-01-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN0667dd81-5633-494e-857e-45fa276fe72c2
309367clotrimazole 10 MG/ML Topical CreamSCD0667dd81-5633-494e-857e-45fa276fe72c2
309367clotrimazole 1 % Topical CreamSY0667dd81-5633-494e-857e-45fa276fe72c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-980-00553190980001 TUBE in 1 BOX (55319-980-00) / 14 g in 1 TUBE1 tube2024-01-01NoNoCurrent