FDA.reportPublic FDA data

Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner

Product NDC
69423-571
11-digit product format
694230571
Labeler code
69423
Product ID
69423-571_464189a3-f971-1a18-e063-6394a90af91e
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
PYRITHIONE ZINC
Active strength
.5 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
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.5 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
1043014Internal 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
c95e82e4-74fb-9dbf-e053-2a95a90a93e5Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69423-571-402023-05-09Royal Oils by head and shoulders ® Mosisture Renewal Scalp Balancing Conditioner
69423-571-932023-05-09Royal Oils by head and shoulders ® Mosisture Renewal Scalp Balancing Conditioner
69423-571-402023-01-30Royal Oils by head and shoulders ® Mosisture Renewal Scalp Balancing Conditioner
69423-571-932023-01-30Royal Oils by head and shoulders ® Mosisture Renewal Scalp Balancing Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-571-40Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner400 mL in 1 BOTTLE, PLASTICLOTION4004
69423-571-93Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner930 mL in 1 BOTTLE, PUMPLOTION9304
69423-571-40Royal Oils by Head and Shoulders Scalp Care Dual Pack400 mL in 1 BOTTLE, PLASTICLOTION400 mL0.5 g in 100mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-571ROYAL OILS BY HEAD AND SHOULDERS MOISTURE RENEWAL SCALP BALANCING CONDITIONER (PYRITHIONE ZINC) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, Legacy NDC, 2 package rows20241220_c95e82e4-74fb-9dbf-e053-2a95a90a93e5.zip
69423-571ROYAL OILS BY HEAD AND SHOULDERS SCALP CARE DUAL PACK (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, Legacy NDC20240926_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 9 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DandruffPYRITHIONE ZINC 1%Meijer, Inc.28525947-97f6-4b3f-b8bd-596ffcf611882026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Dry ScalpPYRITHIONS ZINCMeijer, Inc.57a944af-397f-41d9-bfe0-7cac0dd26cb12026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCMeijer, Inc.9ca4dd70-3dca-4d5a-a13d-51a5dbf92af02026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut KitPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b33d7cd-93ae-6ec9-e063-6294a90afc632026-02-19WarningsExact identifier
application number: M032
DandruffSELENIUM SULFIDEMeijer, Inc.c0e4f8cb-74fc-4c0d-9721-f87aa2aa19922026-02-19Warnings, Adverse reactionsExact identifier
application number: M032
Selsun Blue Naturals Itchy, Dry ScalpSALICYLIC ACIDChattem, Inc.ed031a0f-7467-4b2c-a6b6-95306f6ee8282026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b1a4f24-ff9b-9677-e063-6294a90a9c222026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Coconut 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7cc1c6c8-27cd-6d9e-e053-2991aa0a99df2026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Tea Tree Oil 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company96b37f23-230f-0652-e053-2a95a90a1f642026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company38921198-56d3-ab01-e063-6394a90a89b92026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Smooth and Silky 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb592026-02-18WarningsExact identifier
application number: M032
Head and Shoulders Hydrating CoconutPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company4b20caa0-9ec6-3bfc-e063-6294a90ac68e2026-02-18WarningsExact identifier
application number: M032
Selsun Blue 2-in-1SELENIUM SULFIDEChattem, Inc.f97e458c-cce3-498f-81fc-1b96a4e8f50a2026-02-18WarningsExact identifier
application number: M032
Selsun Blue Itchy Dry ScalpPYRITHIONE ZINCChattem, Inc.c491014d-f8c7-46bb-b065-eaf5ea8428602026-02-18WarningsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI77b2e0da-a6d7-42b5-92af-4e7979817b782026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Dry Scalp CarePYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFI064ff929-d965-4b1a-98a9-f2779f346d7f2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFId7c4507e-7f74-4bcd-9b0e-0b097193a1a82026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCUnited Natural Foods, Inc. dba UNFIecc20b71-eb6b-43ed-86bc-32d61641ee3a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
DandruffPYRITHIONE ZINCTKC Holdings, Inc.c3bc9a89-b1f3-4b7a-bebb-00c341956d602026-02-17Warnings, Adverse reactionsExact identifier
application number: M032
Everyday Clean DandruffPYRITHIONE ZINCValu Merchandisers Companybb0a74e0-2312-4444-b7e1-19a9a3a7007e2026-02-16Warnings, Adverse reactionsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044465head & shoulders 0.5 % Medicated ShampooPSNc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1043014zinc pyrithione 0.5 % Medicated ConditionerPSNc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBDc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCDc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1044465Head & Shoulders 0.5 % ConditionerSYc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1044465Head & Shoulders 5 MG/ML Medicated ShampooSYc95e82e4-74fb-9dbf-e053-2a95a90a93e54
1043014zinc pyrithione 0.5 % Medicated ShampooSYc95e82e4-74fb-9dbf-e053-2a95a90a93e54
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 startMarketing endSampleExclude flagStatus
69423-571-4069423057140400 mL in 1 BOTTLE, PLASTIC (69423-571-40) 400 ml2021-05-010000-00-00NoNoCurrent
69423-571-9369423057193930 mL in 1 BOTTLE, PUMP (69423-571-93) 930 ml2021-05-010000-00-00NoNoCurrent