FDA.reportPublic FDA data

Sebex

Product NDC
0536-1962
11-digit product format
005361962
Labeler code
0536
Product ID
0536-1962_8d66d5eb-fb17-4194-8b25-f7916a739930
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid, Sulfur
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-29
Substance
SALICYLIC ACID; SULFUR
Active strength
20; 20 mg/1000mL; mg/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct0536-1962EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-19620536-1962-97EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sebex
Brand name suffix
Antidandruff, anti-seborrheic dermatitis, anti-psoriasis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/1000mL
SULFUR20 mg/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204638Internal RxNorm lookup
210177Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aec81d61-1d28-490f-9654-f66bd4a30ffaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1962-97SebexAntidandruff, anti-seborrheic dermatitis, anti-psoriasis118 mL in 1 BOTTLESHAMPOO1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1962-97ML - Milliliter0536-19629f5be5fd-d31e-4405-9565-770a612c1f8812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
salicylic acidACTIVE INGREDIENTO414PZ4LPZSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
sulfurACTIVE INGREDIENT70FD1KFU70SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
salicylic acidACTIVE MOIETYO414PZ4LPZSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
sulfurACTIVE MOIETY70FD1KFU70SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
DISODIUM COCOAMPHODIPROPIONATEINACTIVE INGREDIENT6K8PRP397MSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
LANOLININACTIVE INGREDIENT7EV65EAW6HSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
OCTOXYNOL-1INACTIVE INGREDIENT20CAX7IO75SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ESEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM0SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RSEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1962SEBEX ANTIDANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS (SALICYLIC ACID, SULFUR) SHAMPOO [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 1 package rows20240302_aec81d61-1d28-490f-9654-f66bd4a30ffa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mielle Lavender and Lychee Scalp Soothing Daily RefresherPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company51033795-843b-844a-e063-6394a90ad0912026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp Soothing ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5103ddfe-c5a1-3c4d-e063-6294a90aa4622026-05-04WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec19b9b8-b97f-5277-e053-2a95a90a3c1e2026-05-03WarningsExact identifier
application number: M032
Pyrithione ZincCVSApollo Health and Beauty Care34047084-0b26-2385-e063-6394a90a204e2026-05-03WarningsExact identifier
application number: M032
CVS Itchy ScalpPYRITHIONE ZINCApollo Health and Beauty Care372b25d8-10b0-a049-e063-6394a90a4f612026-05-03WarningsExact identifier
application number: M032
CVS ANTI DANDRUFFPYRITHIONE ZINCApollo Health and Beauty Care3415172f-5a31-1085-e063-6394a90aabdc2026-05-03WarningsExact identifier
application number: M032
ProBliva Folliculitis .shampoo.SELENIUMDISULFIDE 1%CAVTECH HOLDING LLC502caa29-f817-cc12-e063-6394a90a22402026-04-23WarningsExact identifier
application number: M032
Dermoia DandruffPYRITHIONE ZINCTreasurewise LLC7884bd3e-62ab-4fcd-8870-0a941c3feadb2026-04-22WarningsExact identifier
application number: M032
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCAmazon.com Services LLC6a634331-eb08-4f18-8a57-692d089180822026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCBetter Living Brands, LLCeb1e3236-5981-46c3-ae06-bed61f02a3282026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCTarget Corporationcc3df9d0-0c16-4176-99d7-d0aec2366f2c2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCTarget Corporationa9d92e08-a77f-45dd-b95a-9923202df40b2026-04-21Warnings, Adverse reactionsExact identifier
application number: M032
DovePYRITHIONE ZINCConopco, Inc. d/b/a/ Unilever7885a86b-f1a4-f2cc-e053-2991aa0ab6772026-04-20WarningsExact identifier
application number: M032
BalancingZINC PYRITHIONEZero Flakes Given, Inc.984780fd-4969-150b-e053-2995a90aed772026-04-16WarningsExact identifier
application number: M032
RestoringPYRITHIONE ZINCZero Flakes Given, Inc.4f9934e4-ec37-9f68-e063-6394a90ab9a42026-04-16WarningsExact identifier
application number: M032
BalancingPYRITHIONE ZINCZero Flakes Given, Inc.4f9a51ba-aea6-081f-e063-6394a90a41222026-04-16WarningsExact identifier
application number: M032
Dove Men CareANTI-DANDRUFF GENTLE CLEAN 2 IN 1 SHAMPOO AND CONDITIONERConopco d/b/a Unilever4ef4b64f-e75d-a2ae-e063-6394a90abd802026-04-08WarningsExact identifier
application number: M032
DoveSOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF CONDITIONERConopco d/b/a Unilever4ef55722-df78-0e4c-e063-6294a90a85402026-04-08WarningsExact identifier
application number: M032
Dove Men CareFORTIFYING SHAMPOO AND CONDITIONER ANTI-DANDRUFF 2 IN 1 PYRITHIONE ZINC SHAMPOOConopco d/b/a Unilever4ecf22e8-e318-26f7-e063-6294a90a54772026-04-07WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204638salicylic acid 2 % / sulfur 2 % Medicated ShampooPSNaec81d61-1d28-490f-9654-f66bd4a30ffa7
210177Sebex 2 % / 2 % Medicated ShampooPSNaec81d61-1d28-490f-9654-f66bd4a30ffa7
210177salicylic acid 20 MG/ML / sulfur 20 MG/ML Medicated Shampoo [Sebex]SBDaec81d61-1d28-490f-9654-f66bd4a30ffa7
204638salicylic acid 20 MG/ML / sulfur 20 MG/ML Medicated ShampooSCDaec81d61-1d28-490f-9654-f66bd4a30ffa7
204638salicylic acid 2 % / sulfur 2 % Medicated ShampooSYaec81d61-1d28-490f-9654-f66bd4a30ffa7
210177Sebex (salicylic acid 2 % / sulfur 2 % ) Medicated ShampooSYaec81d61-1d28-490f-9654-f66bd4a30ffa7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1962-9700536196297118 mL in 1 BOTTLE (0536-1962-97) 118 ml2012-10-290000-00-00NoNoCurrent