FDA.reportPublic FDA data

Head and Shoulders Aloe Vera Soothing Relief 2in1

Product NDC
84126-054
11-digit product format
841260054
Labeler code
84126
Product ID
84126-054_47486ea9-2ad0-ebe4-e063-6294a90a92c4
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
PYRITHIONE ZINC
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 Aloe Vera Soothing Relief 2in1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup
1043244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27ec4d49-a783-cacd-e063-6394a90adbbeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-054-37Head and Shoulders Aloe Vera Soothing Relief 2in1370 mL in 1 BOTTLE, PLASTICSHAMPOO3702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-054HEAD AND SHOULDERS ALOE VERA SOOTHING RELIEF 2IN1 (PYRITHIONE ZINC) SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20241129_27ec4d49-a783-cacd-e063-6394a90adbbe.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 11 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everyday Clean DandruffPYRITHIONE ZINCRetail Business Services, LLC8fb44204-b763-4aa5-a6db-94d1b4d98b652026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc1d8c237-1ca8-4fdb-ba94-787d3a9e61112026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCRetail Business Services, LLC592ec7c5-44b8-405b-88a2-f02aa6c620f02026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCRetail Business Services, LLC37357176-913d-4dd7-a565-ad21d4ad60a82026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCRetail Business Services, LLCc8c82495-f09a-4ec1-9036-e464845e02f92026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLCec9d36ae-cf4e-4841-a13e-5cb0fe64c4fa2026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCRetail Business Services, LLC841429c3-e15c-41cc-9ca8-6b5a21a215872026-02-06Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.56c2b8c2-69ea-4343-ae69-43f5966261c22026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCPublix Super Markets, Inc.8a204a2c-6dcb-4fc4-b265-9b95da2042362026-02-05Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCHarris Teeter8594a944-a67e-4dbe-8d31-7099410ff4842026-02-04Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCAmazon.Com Services LLCe30896df-e4b2-4b1f-a226-a26055a4a1212026-02-03Warnings, Adverse reactionsExact identifier
application number: M032
Oribe Serene Scalp Anti DandruffORIBE SERENE SCALP ANTI DANDRUFFOribe Hair Care LLC34c4abb5-6f96-4866-a37f-4f9be6c43f2b2026-01-30WarningsExact identifier
application number: M032
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact identifier
application number: M032
Head and Shoulders Charcoal DailyPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company69abc8fa-eee5-d36f-e053-2991aa0a940b2026-01-28WarningsExact identifier
application number: M032
WeCare Anti-DandruffANTIDANDRUFF SHAMPOODynarex Corporation7fad58a3-5537-f87a-e053-2991aa0a7cdb2026-01-28WarningsExact identifier
application number: M032
TriDerma Psoriasis Control Face and Body CreamSALICYLIC ACIDGenuine Virgin Aloe Corporation66eeaf72-1fb4-4df0-9198-41f1143c67b32026-01-27WarningsExact identifier
application number: M032
TRIDERMA Psoriasis ControlSALICYLIC ACIDGenuine Virgin Aloe Corporation16ba7145-0e8c-48b8-b557-43ac1be317ac2026-01-27WarningsExact identifier
application number: M032
DHS tar gelCOAL TARPerson and Coveye17bd664-748b-417c-a247-9acc7bc7eec32026-01-23WarningsExact identifier
application number: M032
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDGarcoa, Inc.620617e3-0ee1-469a-ad2b-0dda957627cc2026-01-21WarningsExact identifier
application number: M032
Aloe Coal 02 ConditionerPYRITHIONE ZINCT. SPRUILL, LLCe8e1fbe8-7de3-4a8e-bace-b7b2e4db18282026-01-19WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSN27ec4d49-a783-cacd-e063-6394a90adbbe2
209884zinc pyrithione 1 % Medicated ShampooPSN27ec4d49-a783-cacd-e063-6394a90adbbe2
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD27ec4d49-a783-cacd-e063-6394a90adbbe2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD27ec4d49-a783-cacd-e063-6394a90adbbe2
1043244Head & Shoulders 1 % Medicated ShampooSY27ec4d49-a783-cacd-e063-6394a90adbbe2
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY27ec4d49-a783-cacd-e063-6394a90adbbe2
209884zinc pyrithione 1 % Medicated ConditionerSY27ec4d49-a783-cacd-e063-6394a90adbbe2
209884zinc pyrithione 1 % Medicated ShampooSY27ec4d49-a783-cacd-e063-6394a90adbbe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-054-3784126005437370 mL in 1 BOTTLE, PLASTIC (84126-054-37) 370 ml2024-02-01NoNoCurrent