UREA HYDRATING TOPICAL

Product NDC
42192-115
11-digit product format
421920115
Labeler code
42192
Product ID
42192-115_68900b38-ea80-dbe3-e053-2a91aa0ade35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Acella Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-05-21
Marketing end
0000-00-00
Substance
UREA
Active strength
35 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct42192-115DDiscontinued by firm2026-08-17
excluded packagepackage42192-11542192-115-15DDiscontinued by firm2026-08-17

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 · 18 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 packagepackage42192-115-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42192-115-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42192-115-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42192-115-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42192-115-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42192-115-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42192-115-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42192-115-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42192-115-150efc9e666f02…f202fb6c5f17…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-115-15GM - Gram42192-11577664ad7-969d-4bf3-8c7a-9d18cc6989ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UREAACTIVE INGREDIENT8W8T17847WUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
UREAACTIVE MOIETY8W8T17847WUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
BUTANEINACTIVE INGREDIENT6LV4FOR43RUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
ETHYLPARABENINACTIVE INGREDIENT14255EXE39UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
PROPANEINACTIVE INGREDIENTT75W9911L6UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RUREA HYDRATING TOPICAL (UREA) AEROSOL, FOAM [ACELLA PHARMACEUTICALS]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-115-1542192011515150 g in 1 CANISTER (42192-115-15) 150 g2010-05-210000-00-00NoNoCurrent