FDA.reportPublic FDA data

EuCutaSol

Product NDC
63347-301
Requested package NDC
63347-301-01
11-digit product format
633470301
Labeler code
63347
Product ID
63347-301_17d905d8-0957-4f18-b6c2-8e176f72d546
Type
HUMAN OTC DRUG
Nonproprietary name
COAL TAR
Dosage form
CREAM
Route
TOPICAL
Labeler
Blaine Labs Inc.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
COAL TAR
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63347-30163347-301-01DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63347-301-012022-02-18da75a9c5-62ef-4dbb-becf-d343c41f6315
63347-301-022022-02-18da75a9c5-62ef-4dbb-becf-d343c41f6315
63347-301-012022-01-28da75a9c5-62ef-4dbb-becf-d343c41f6315
63347-301-022022-01-28da75a9c5-62ef-4dbb-becf-d343c41f6315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAL TARACTIVE INGREDIENTR533ESO2ECEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
COAL TARACTIVE MOIETYR533ESO2ECEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
ARCTIUM LAPPA ROOTINACTIVE INGREDIENT597E9BI3Z3EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OGEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
HYDROCORTISONEINACTIVE INGREDIENTWI4X0X7BPJEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999REUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)INACTIVE INGREDIENTRHA9LWJ494EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEUCUTASOL (COAL TAR) CREAM [BLAINE LABS INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-301-0163347030101112 g in 1 JAR (63347-301-01) 112 g2012-07-010000-00-00NoNoCurrent