Fungi Nail Toe and Foot

Product NDC
55505-174
11-digit product format
555050174
Labeler code
55505
Product ID
55505-174_59af9b22-9d8a-4754-bdf0-6aa971657c57
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Undecylenate Undecylenic acid
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kramer Laboratories
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
ZINC UNDECYLENATE; UNDECYLENIC ACID
Active strength
20 g/20g; g/20g
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55505-174DDiscontinued by firm2026-10-05
excluded packagepackage55505-17455505-174-50DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55505-174-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55505-174-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55505-174-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55505-174-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55505-174-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55505-174-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55505-174-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55505-174-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55505-174-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55505-174-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55505-174-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55505-174-50557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55505-174-50GM - Gram55505-1744f03b2ea-d53f-467f-aca2-a408ff2884bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
ZINC UNDECYLENATEACTIVE INGREDIENT388VZ25DURFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08FUNGI NAIL TOE AND FOOT MS (ZINC UNDECYLENATE UNDECYLENIC ACID) OINTMENT [KRAMER LABORATORIES]4