FDA.reportPublic FDA data

Head and Shoulders Clinical Strength Cooling Itch Relief

Product NDC
84126-183
11-digit product format
841260183
Labeler code
84126
Product ID
84126-183_40465046-ae04-da8c-e063-6294a90a422c
Type
HUMAN OTC DRUG
Nonproprietary name
Selenium Sulfide
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
SELENIUM SULFIDE
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Head and Shoulders Clinical Strength Cooling Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SELENIUM SULFIDE1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z69D9E381QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204642Internal RxNorm lookup
1549328Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
40464e2d-f738-33ec-e063-6394a90a02c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-183-01Head and Shoulders Clinical Strength Cooling Itch Relief400 mL in 1 BOTTLE, PLASTICSHAMPOO4001
84126-183-01Head and Shoulders Clinical Strength Cooling Itch Relief2 in 1 CARTONSHAMPOO21
84126-183-40Head and Shoulders Clinical Strength Cooling Itch Relief400 mL in 1 BOTTLE, PLASTICSHAMPOO4001

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 10 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dry ScalpPYRITHIONE ZINCValu Merchandisers Company6349fd91-675b-4489-8b57-e584f718ca3f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCValu Merchandisers Companye9fc676c-0313-430f-a422-6dba51241bd52026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCValu Merchandisers Companyd5dd333d-fea5-4e03-bd9f-cbc28ea48a802026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI66f301bf-8e2e-43ce-b6b8-0983fe795f012026-02-16Warnings, Adverse reactionsExact identifier
application number: M032
Tuymec Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOO.Guangzhou Jingliang Cosmetics Co., Ltd.4ae93408-5c8f-c0a5-e063-6394a90a9e0d2026-02-15WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC4ac42528-9210-6936-e063-6294a90a41682026-02-14WarningsExact identifier
application number: M032
OLIVITA 5% Minoxidil5% MINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4acbdf3d-976a-2cba-e063-6294a90a35e62026-02-14WarningsExact identifier
application number: M032
VENANOCI MinoxidilMINOXIDILShenzhen Xinxin Yunhai Technology Co., Ltd.4acc38aa-13da-981b-e063-6294a90aede52026-02-14WarningsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCTopco Associates LLCfc568c8f-0d59-4b26-8f72-ea70e43166872026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTopco Associates LLCa0f2c58b-bb17-42a3-bd90-be771f60ef202026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTopco Associates LLC706b856c-ce89-4860-bc5d-9803deb469e72026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCTopco Associates LLC3300bfd5-ae84-4bc8-a4cd-05472b498fb72026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCTopco Associates LLCc0abb41f-9df0-4493-8452-592ec30c79242026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCTopco Associates LLC7da1e057-a69e-4b89-a309-919d88da3b932026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Pyrithione zincPYRITHIONE ZINCTopco Associates LLC2c1420a8-404f-4fd7-8f07-cd441b390ac22026-02-13Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCWinCo Foods, LLC2581c531-c068-4dae-b569-3b1f86dad0662026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONE ZINCWinCo Foods, LLC4fca1200-dc6c-4e6e-b09c-2ec8ac0fa4112026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCWinCo Foods, LLC8bd391ae-0eeb-4e7d-b1e5-20e4adb1da172026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCYour Military Exchangesa62b282f-e928-42bb-b595-d5f2066aac632026-02-12Warnings, Adverse reactionsExact identifier
application number: M032
natouchPYRITHIONE ZINCNatouch LLC0f330e2d-25d7-5e0e-e063-6394a90acda92026-02-10WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549328Head & Shoulders Clinical Strength 1 % Medicated ShampooPSN40464e2d-f738-33ec-e063-6394a90a02c21
204642selenium sulfide 1 % Medicated ShampooPSN40464e2d-f738-33ec-e063-6394a90a02c21
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Strength]SBD40464e2d-f738-33ec-e063-6394a90a02c21
204642selenium sulfide 10 MG/ML Medicated ShampooSCD40464e2d-f738-33ec-e063-6394a90a02c21
1549328Head & Shoulders Clinical Solutions 10 MG/ML Medicated ShampooSY40464e2d-f738-33ec-e063-6394a90a02c21
1549328Head & Shoulders Clinical Strength 10 MG/ML Medicated ShampooSY40464e2d-f738-33ec-e063-6394a90a02c21
204642selenium sulfide 1 % Lotion ShampooSY40464e2d-f738-33ec-e063-6394a90a02c21
204642selenium sulfide 1 % Medicated ShampooSY40464e2d-f738-33ec-e063-6394a90a02c21
1549328selenium sulfide 10 MG/ML Medicated Shampoo [Head & Shoulders Clinical Solutions]SY40464e2d-f738-33ec-e063-6394a90a02c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-183-01841260183012 BOTTLE, PLASTIC in 1 CARTON (84126-183-01) / 400 mL in 1 BOTTLE, PLASTIC2025-06-01NoNoCurrent
84126-183-4084126018340400 mL in 1 BOTTLE, PLASTIC (84126-183-40) 400 ml2025-06-01NoNoCurrent