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 4 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
application number: M032
5% Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.5278c9c2-4bce-fed4-e063-6394a90a7f332026-05-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.527902b1-2018-4546-e063-6394a90a70522026-05-23WarningsExact identifier
application number: M032
VeraRoot Minoxidil Topical SolutionVERAROOT MINOXIDIL TOPICAL SOLUTIONShenzhen Xinxin Yunhai Technology Co., Ltd.52794d53-43ba-98ea-e063-6394a90a80a92026-05-23WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc521c263e-d29c-2564-e063-6394a90a2e1d2026-05-18WarningsExact identifier
application number: M032
Matrix Biolage Scalp Sync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Incea6fb9ff-8895-4754-9fd7-d24c235f01322026-05-15WarningsExact identifier
application number: M032
Simply Clean DandruffPYRITHIONE ZINCAldi, Inc6db037d4-c781-4cee-a4d5-52a93eccd55f2026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCAldi, Incb27d1453-d825-43ac-8a44-d7a5015ab9772026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Incd6a704df-edd8-4960-a088-246519e2aecf2026-05-12WarningsExact identifier
application number: M032
Kopa Haiku Seborrheic Dermatitis Face CreamSALICYLIC ACID 0.5% AND ZINC PYRITHIONE 0.25%Trovina Co. Ltd483450d2-e38b-56ec-e063-6394a90acb5b2026-05-10WarningsExact identifier
application number: M032
Mens SportPYRITHIONE ZINCApollo Health and Beauty Care1d1203ea-9994-31bb-e063-6394a90a9ec82026-05-08WarningsExact identifier
application number: M032
Classic CleanSHAMPOOApollo Health and Beauty Carefa684d69-771a-d3d4-e053-6294a90a13442026-05-08WarningsExact identifier
application number: M032
CVS GoldSELENIUM SULFIDEApollo Health and Beauty Care1d12ca6a-2734-0534-e063-6294a90a27062026-05-08WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCApollo Health and Beauty Care0a4ab6fa-bf74-fe6e-e063-6394a90aa6fc2026-05-08WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Total Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5126db42-4fd3-319e-e063-6394a90aab3f2026-05-06WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDCISNE GROUP LLC512abbb6-ea6a-70b1-e063-6294a90a2a7c2026-05-06WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec1a09dc-7fb6-6d89-e053-2a95a90a48412026-05-05WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDGuangzhou Pallas Cosmetics Co.,Ltd.51178cb9-f83f-2459-e063-6394a90a3f1e2026-05-05WarningsExact identifier
application number: M032
Recuren Plus Balanced ScalpSALICYLIC ACIDREGENEREN PLUS LTD50c27b0f-9bf5-de9c-e063-6394a90af41a2026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp MoisturizingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company510212e9-1d12-3a0a-e063-6294a90a1d782026-05-04WarningsExact 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