Anti Dandruff

Product NDC
70550-329
11-digit product format
705500329
Labeler code
70550
Product ID
70550-329_ecd389e1-213e-24bc-e053-2a95a90ad556
Type
HUMAN OTC DRUG
Nonproprietary name
Keranique Anti Dandruff Shampoo
Dosage form
LOTION
Route
TOPICAL
Labeler
Profectus Beauty, LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-06
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct70550-329IInactivated by FDA2026-07-31
excluded packagepackage70550-32970550-329-01IInactivated by FDA2026-07-31

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70550-329-012024-01-30C16284748780-11030e365-12cb-111a-e063-dadaa90a10e2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70550-329-01Anti Dandruff1 in 1 CARTONLOTION12
70550-329-01Anti Dandruff240 mL in 1 BOTTLE, PLASTICLOTION2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70550-329ANTI DANDRUFF (KERANIQUE ANTI DANDRUFF SHAMPOO) LOTION [PROFECTUS BEAUTY, LLC]2Legacy NDC, 2 package rows20221107_6ce5f0d0-efbb-4a6a-a813-544586b16f72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205023salicylic acid 3 % Medicated ShampooPSN6ce5f0d0-efbb-4a6a-a813-544586b16f722
205023salicylic acid 30 MG/ML Medicated ShampooSCD6ce5f0d0-efbb-4a6a-a813-544586b16f722
205023salicylic acid 3 % Medicated ShampooSY6ce5f0d0-efbb-4a6a-a813-544586b16f722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70550-329-01705500329011 BOTTLE, PLASTIC in 1 CARTON (70550-329-01) > 240 mL in 1 BOTTLE, PLASTIC2022-11-060000-00-00NoNoCurrent