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 26 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
As I Am Dry and Itchy Scalp CarePYRITHIONE ZINCSalon Commodities, Inc.71ea4820-4160-41c2-e053-2a95a90a127d2024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care Co WashPYRITHIONE ZINCSalon Commodities, Inc.71edee79-87ed-ff7c-e053-2995a90ae1302024-10-09WarningsExact identifier
application number: M032
Vanicream Z-BarPYRITHIONE ZINCPharmaceutical Specialties, Inc.21c84000-5d08-ae53-e063-6294a90a23622024-10-03WarningsExact identifier
application number: M032
Head and Shoulders Classic Clean DandruffPYRITHIONE ZINCNavajo Manufacturing Company Inc3886d51a-b946-4862-a237-e8232df956372024-10-02WarningsExact identifier
application number: M032
CVS Daily Dandruff Anti-dandruffPYRITHIONE ZINCCVS Health705f5ced-a245-42c8-a32f-baaddaa11c6e2024-09-27WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Healthcff51af6-84de-4ba5-ac99-9bc42a65c9a52024-09-24WarningsExact identifier
application number: M032
VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical StrengthSALICYLIC ACIDVerb Products Inc.18bddd16-e001-445c-9647-801defc1d5272024-09-03WarningsExact identifier
application number: M032
Denorex Severe ItchCOAL TARNeoteric Cosmetics, Inc.213ccbc4-2f52-58b6-e063-6294a90ae2482024-09-03WarningsExact identifier
application number: M032
SORARESALSALICYLIC ACIDSummer Herbal Inc.af734362-057b-4011-bf4e-c4e4dd67f68c2024-09-03WarningsExact identifier
application number: M032
ion 2 in 1 anti-dandruff Anti-dandruffPYRITHIONE ZINCArcadia Beauty Labs LLC38631b45-b222-4a25-8180-25970dabdffc2024-08-28WarningsExact identifier
application number: M032
TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARTopco Associates LLC070a5249-0b37-4b7f-a55b-609a0d8504d22024-08-22WarningsExact identifier
application number: M032
J1003005 Jason Dandruff ReliefSULFUR, SALICYLIC ACIDThe Hain Celestial Group, Inc.625e8306-78c4-3317-e053-2991aa0afe812024-07-31WarningsExact identifier
application number: M032
Jason Dandruff Relief Treatment 2 in 1ZINC PYRITHIONEThe Hain Celestial Group, Inc4afa1048-7a76-4562-8dcf-9252d5bfa48a2024-07-31WarningsExact identifier
application number: M032
Alba Natural Acnedote AstringentSALICYLIC ACIDThe Hain Celestial Group, Inc.939f90e7-e1de-4ca3-a484-90f1b87797d62024-07-31WarningsExact identifier
application number: M032
Matrix Biolage ScalpSync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Inc8564f2cf-b680-4e2c-8451-f345c9852c1a2024-07-18WarningsExact identifier
application number: M032
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
application number: M032
VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-DandruffSELENIUM SULFIDE, MICRONIZEDL'Oreal USA Products Incdeae26e0-53f0-442b-959c-0f925a102db02024-06-25WarningsExact identifier
application number: M032
VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruffSELENIUM SULFIDE, MICRONIZEDPRODUCTOS CAPILARES L'OREAL SA3fcb03fc-552a-4b02-981e-2ff84142da962024-06-25WarningsExact identifier
application number: M032
Dercos Salicylic Acid Anti-Dandruff SerumSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SA024f9299-ee6c-48e3-89e7-96b7db060c302024-06-20WarningsExact 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