FDA.reportPublic FDA data

Head and Shoulders Royal Oils Instant Soothe Scalp

Product NDC
69423-309
Requested package NDC
69423-309-50
11-digit product format
694230309
Labeler code
69423
Product ID
69423-309_464059e8-1f3b-f3ba-e063-6294a90a2dab
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
2018-08-30
Substance
PYRITHIONE ZINC
Active strength
.1 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69423-30969423-309-50DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 31 · 614 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Anti-DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.543a431f-21fb-df9e-e063-6394a90a6c362026-06-14WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032

Additional Listing Data#

Finished product
Yes
Brand name base
Head and Shoulders Royal Oils Instant Soothe Scalp
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC.1 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
1052676Internal RxNorm lookup
2104634Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b20f226-3b0a-2ae5-e053-2a91aa0a2f5aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-309-122024-01-30C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502024-01-30C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122022-11-17C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502022-11-17C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122022-01-28C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502022-01-28C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122021-11-14C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502021-11-14C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-122021-07-23C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-502021-07-23C16284748780-1c7ccaba7-1bd5-fd44-e053-dadaa90aa01bHead and Shoulders ® Royal Oils Instant Soothe Scalp Elixir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-309-12Head and Shoulders Royal Oils Instant Soothe Scalp125 mL in 1 BOTTLE, PUMPLOTION1258
69423-309-12Head and Shoulders Royal Oils Instant Soothe Scalp1 in 1 CARTONLOTION18
69423-309-50Head and Shoulders Royal Oils Instant Soothe Scalp50 mL in 1 BOTTLE, PUMPLOTION508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-309HEAD AND SHOULDERS ROYAL OILS INSTANT SOOTHE SCALP (PYRITHIONE ZINC) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]7Current NDC, Legacy NDC, 3 package rows20240907_7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2104634Head & Shoulders 0.1 % Topical LotionPSN7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
1052676pyrithione zinc 0.1 % Topical LotionPSN7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
2104634zinc pyrithione 1 MG/ML Topical Lotion [Head & Shoulders]SBD7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
1052676zinc pyrithione 1 MG/ML Topical LotionSCD7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
2104634Head & Shoulders 0.1 % Topical LotionSY7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
2104634Head & Shoulders 1 MG/ML Topical LotionSY7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8
1052676zinc pyrithione 0.1 % Topical LotionSY7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-309-506942303095050 mL in 1 BOTTLE, PUMP (69423-309-50) 50 ml2019-11-210000-00-00NoNoCurrent