TOPCARE

Product NDC
36800-618
11-digit product format
368000618
Labeler code
36800
Product ID
36800-618_518763f2-eeb4-48e9-b869-bedc4645a175
Type
HUMAN OTC DRUG
Nonproprietary name
SELENIUM SULFIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-28
Marketing end
0000-00-00
Substance
SELENIUM SULFIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct36800-618IInactivated by FDA2026-07-31
excluded packagepackage36800-61836800-618-14IInactivated 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-618-142020-01-31C16284748780-19d75b9d0-f790-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-618-14TOPCAREGENTLE DANDRUFF CLINICAL STRENGTH420 mL in 1 BOTTLE, PLASTICLIQUID4201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SELENIUM SULFIDEACTIVE INGREDIENTZ69D9E381QTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SELENIUM SULFIDEACTIVE MOIETYZ69D9E381QTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
AMMONIUM LAURETH-3 SULFATEINACTIVE INGREDIENT896SJ235FNTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
AMMONIUM XYLENESULFONATEINACTIVE INGREDIENT4FZY6L6XCMTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFATOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-618TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH (SELENIUM SULFIDE) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20140730_1004a6cb-2fbe-4822-800a-4f7296a82ed2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204642selenium sulfide 1 % Medicated ShampooPSN1004a6cb-2fbe-4822-800a-4f7296a82ed21
204642selenium sulfide 10 MG/ML Medicated ShampooSCD1004a6cb-2fbe-4822-800a-4f7296a82ed21
204642selenium sulfide 1 % Lotion ShampooSY1004a6cb-2fbe-4822-800a-4f7296a82ed21
204642selenium sulfide 1 % Medicated ShampooSY1004a6cb-2fbe-4822-800a-4f7296a82ed21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
36800-618-1436800061814420 mL in 1 BOTTLE, PLASTIC420 mlHistorical