FDA.reportPublic FDA data

Progenesis

Product NDC
82349-139
11-digit product format
823490139
Labeler code
82349
Product ID
82349-139_f1e53df5-928a-0e92-e053-2995a90a5e62
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-Dandruff Shampoo
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Palcare Enterprises Inc
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-02-01
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82349-139DDiscontinued by firm2026-07-31
excluded packagepackage82349-13982349-139-65DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MG217 Psoriasis Therapeutic Scalp TreatmentCOAL TARWisconsin Pharmacal Company6d3f4685-eb47-445e-86fb-3601d2c110e72018-12-10WarningsExact identifier
MG217 Psoriasis Medicated ConditioningCOAL TARWisconsin Pharmacal Company7cafb511-0ab7-f3b4-e053-2991aa0a2e0b2018-12-10WarningsExact identifier
Overnight ClearingSALICYLIC ACIDDermalogica, Inc.6f6d9bd9-a1c8-4f8c-b7b8-fe9748a06c2c2017-12-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Ask doctor before use if condition covers a large area of the body. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. use caution in exposing skin to sunlight. It may increase your tendency to sunburn for up to 24 hours after application. do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a physician. do not use for prolonged periods without consulting a physician. Stop use and ask a doctor if condition worsens. condition does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. WARNING This product can gose you to chemicals including Coal Tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82349-139-6582349013965250 mL in 1 BOTTLE, PLASTIC (82349-139-65) 250 ml2022-02-010000-00-00NoNoCurrent