FDA.reportPublic FDA data

Royal Oils by Head and Shoulders Scalp Care Dual Pack

Product NDC
84126-003
11-digit product format
841260003
Labeler code
84126
Product ID
84126-003_4642951a-e287-a8c2-e063-6294a90a61ec
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
KIT
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-01
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
Royal Oils by Head and Shoulders Scalp Care Dual Pack
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup
1043014Internal RxNorm lookup
1043244Internal RxNorm lookup
1044465Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1aa02661-4381-4f01-e063-6294a90aec62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-571-40Royal Oils by Head and Shoulders Scalp Care Dual Pack400 mL in 1 BOTTLE, PLASTICLOTION400 mL0.5 g in 100mL3
69423-608-38Royal Oils by Head and Shoulders Scalp Care Dual Pack380 mL in 1 BOTTLE, PLASTICSHAMPOO380 mL1 g in 100mL3
84126-003-01Royal Oils by Head and Shoulders Scalp Care Dual Pack1 in 1 CELLO PACKKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-003ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, 3 package rows20240926_1aa02661-4381-4f01-e063-6294a90aec62.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 8 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simply Clean DandruffPYRITHIONE ZINCOld East Main Co.643f571a-cf08-4f1f-9ad4-2bc68730ff572026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCOld East Main Co.3c433aa9-9451-4820-8b58-632cf6d0c92a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.3afc97ff-6a83-40af-9a61-26f00cfe4fa82026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.1d4966d1-02d9-4b70-acc2-88a8190f920c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Pyrithione zincPYRITHIONE ZINCOld East Main Co.f17154e2-1bcf-43f9-b201-e84d374a05912026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCOld East Main Co.61bf3788-b1e8-4d7e-ac56-cf209ba390852026-03-02Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCThe Kroger Co.835270e7-ba6a-46e8-a617-f5df1c69d4112026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCThe Kroger Co.837d7a14-b312-4dce-a00a-623b503293782026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCThe Kroger Co.d442e1af-e31a-4de6-b358-52e08aedd7ee2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Clean ApplePYRITHIONE ZINCThe Kroger Co.00eb0594-cfa5-4fdb-aca8-650c109979242026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCWalmart Inc.e4fd5d8b-a916-41c3-b05e-a32dd528f00f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCWalmart Inc.23ad86c0-5a75-4f52-8561-483708d415d62026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean 2 in 1PYRITHIONE ZINCWalmart Inc.2bafcad7-1bb7-168e-e063-6394a90a0b9e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M032
Paul Mitchell DandruffZINC PYRITHIONEJohn Paul Mitchell Systems4bc02aa8-86b1-985e-e063-6294a90aa2672026-02-26WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E Bbdf0b3da-db37-4996-b5e5-23cf824d1d1f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCH E B0927361e-a210-4e44-bbe7-fb68b240cf4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCH E B0410f6a6-6602-44fb-b223-586439938e192026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp DandruffPYRITHIONE ZINCH E B626933cb-9c84-4f37-943c-2a9bd21fcea52026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCH E B75342eff-6bff-4fed-bd12-381edd2df6812026-02-24Warnings, Adverse reactionsExact identifier
application number: M032
DandruffSELENIUM SULFIDEH E B182ca790-0713-412a-9111-c0cf40f20d022026-02-24Warnings, Adverse reactionsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044465head & shoulders 0.5 % Medicated ShampooPSN1aa02661-4381-4f01-e063-6294a90aec623
1043244head & shoulders 1 % Medicated ShampooPSN1aa02661-4381-4f01-e063-6294a90aec623
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN1aa02661-4381-4f01-e063-6294a90aec623
209884zinc pyrithione 1 % Medicated ShampooPSN1aa02661-4381-4f01-e063-6294a90aec623
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1aa02661-4381-4f01-e063-6294a90aec623
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD1aa02661-4381-4f01-e063-6294a90aec623
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1aa02661-4381-4f01-e063-6294a90aec623
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD1aa02661-4381-4f01-e063-6294a90aec623
1044465Head & Shoulders 0.5 % ConditionerSY1aa02661-4381-4f01-e063-6294a90aec623
1043244Head & Shoulders 1 % Medicated ShampooSY1aa02661-4381-4f01-e063-6294a90aec623
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1aa02661-4381-4f01-e063-6294a90aec623
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY1aa02661-4381-4f01-e063-6294a90aec623
1043014zinc pyrithione 0.5 % Medicated ShampooSY1aa02661-4381-4f01-e063-6294a90aec623
209884zinc pyrithione 1 % Medicated ConditionerSY1aa02661-4381-4f01-e063-6294a90aec623
209884zinc pyrithione 1 % Medicated ShampooSY1aa02661-4381-4f01-e063-6294a90aec623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-571-4069423057140400 mL in 1 BOTTLE, PLASTIC400 mlHistorical
69423-608-3869423060838380 mL in 1 BOTTLE, PLASTIC380 mlHistorical
84126-003-01841260003011 KIT in 1 CELLO PACK (84126-003-01) * 380 mL in 1 BOTTLE, PLASTIC (69423-608-38) * 400 mL in 1 BOTTLE, PLASTIC (69423-571-40) 1 kit2023-05-01NoNoCurrent