Head and Shoulders Royal Oils Instant Soothe Scalp

Product NDC
69423-309
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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 firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69423-309-50DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69423-309-50DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69423-309-50DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69423-309-50DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69423-309-50DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69423-309-50DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69423-309-50DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69423-309-50DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69423-309-50DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69423-309-50DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69423-309-50DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69423-309-50DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69423-309-12IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69423-309-50IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69423-309-12IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69423-309-50IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69423-309-12IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69423-309-50IInactivated by FDAbd6a592717d7…303034d00443…

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 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#

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

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 3 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032

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
69423-309-12694230309121 BOTTLE, PUMP in 1 CARTON (69423-309-12) / 125 mL in 1 BOTTLE, PUMP2018-08-300000-00-00NoNoCurrent
69423-309-506942303095050 mL in 1 BOTTLE, PUMP (69423-309-50) 50 ml2019-11-210000-00-00NoNoCurrent