FDA.reportPublic FDA data

Therapeutic

Product NDC
49035-497
Requested package NDC
49035-497-30
11-digit product format
490350497
Labeler code
49035
Product ID
49035-497_fb82bef6-4386-4816-b613-fed8f72a032f
Type
HUMAN OTC DRUG
Nonproprietary name
Coal Tar
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Wal-Mart
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-31
Marketing end
0000-00-00
Substance
COAL TAR
Active strength
1 g/100mL
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 packagepackage49035-49749035-497-30DDiscontinued 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-49749035-497-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAL TARACTIVE INGREDIENTR533ESO2ECTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
COAL TARACTIVE MOIETYR533ESO2ECTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
IMIDUREAINACTIVE INGREDIENTM629807ATLTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
LAURETH-4INACTIVE INGREDIENT6HQ855798JTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0THERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
ULTRAMARINE BLUEINACTIVE INGREDIENTI39WR998BITHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1
WATERINACTIVE INGREDIENT059QF0KO0RTHERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-497THERAPEUTIC (COAL TAR) SHAMPOO [WAL-MART]10Legacy NDC20241017_1d788b79-e103-43a0-8ca4-3ea581ef3ddc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-497-30490350497301 BOTTLE, PLASTIC in 1 PACKAGE (49035-497-30) > 177 mL in 1 BOTTLE, PLASTIC2011-08-310000-00-00NoNoCurrent