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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69423-309	69423-309-50	D	Discontinued by firm		2026-10-05

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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69423-309-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69423-309-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69423-309-50	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69423-309-50	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69423-309-50	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69423-309-50	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69423-309-50	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69423-309-50	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69423-309-50	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69423-309-50	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69423-309-50	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69423-309-50	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69423-309-12	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69423-309-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69423-309-12	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69423-309-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69423-309-12	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69423-309-50	I	Inactivated by FDA	`bd6a592717d7…`	`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
Ingredient	Strength
PYRITHIONE ZINC	.1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R953O2RHZ5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052676	Internal RxNorm lookup
2104634	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69423-309-12	2024-01-30	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-50	2024-01-30	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-12	2022-11-17	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-50	2022-11-17	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-12	2022-01-28	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-50	2022-01-28	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-12	2021-11-14	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-50	2021-11-14	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-12	2021-07-23	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir
69423-309-50	2021-07-23	Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69423-309-12	Head and Shoulders Royal Oils Instant Soothe Scalp	125 mL in 1 BOTTLE, PUMP	LOTION	125	8
69423-309-12	Head and Shoulders Royal Oils Instant Soothe Scalp	1 in 1 CARTON	LOTION	1	8
69423-309-50	Head and Shoulders Royal Oils Instant Soothe Scalp	50 mL in 1 BOTTLE, PUMP	LOTION	50	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69423-309	HEAD AND SHOULDERS ROYAL OILS INSTANT SOOTHE SCALP (PYRITHIONE ZINC) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	7	Current NDC, Legacy NDC, 3 package rows	20240907_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 1 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Classic Clean Dandruff	PYRITHIONE ZINC	CARDINAL HEALTH 110, LLC. DBA LEADER	5b22537d-d09c-5bd6-e063-6294a90a48ff	2026-09-10	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cc726c2-3747-6dbf-e063-6294a90a789f	2026-09-09	Warnings	Exact identifier application number: M032
Leader Maximum Strength Therapeutic Dandruff	SALICYLIC ACID	CARDINAL HEALTH 110, LLC. DBA LEADER	5afb2260-5b50-de95-e063-6394a90a5a47	2026-09-08	Warnings	Exact identifier application number: M032
ANTI-DANDRUFF	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	5ac93feb-eb6d-7563-e063-6294a90ad2e0	2026-09-05	Warnings	Exact identifier application number: M032
Dr Marvel ANTI DANDRUFF SCALP SERUM	SELENIUM SULFIDE SALICYLIC ACID	Guangzhou Liyan Cosmetics Technology Co., Ltd.	5aaeddff-72f9-3687-e063-6394a90ae5dc	2026-09-04	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Restore Nourishing Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	5a834d00-cc79-1a8e-e063-6294a90ab245	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Purify Clarifying Pre-Shampoo	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a84c545-4570-b078-e063-6394a90a8c5a	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Purify Volumizing	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a8627ec-cfd8-d0f6-e063-6394a90ab488	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Soothe Cooling	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5a87ed71-87e7-a7b7-e063-6294a90ac897	2026-09-02	Warnings	Exact identifier application number: M032
Head and Shoulders Scalp Restore Nourishing	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	5a8a42d2-8610-1dfb-e063-6294a90abc7a	2026-09-02	Warnings	Exact identifier application number: M032
Koi Beauty 5% Minoxidil Hair Growth Kit	5% MINOXIDIL HAIR GROWTH KIT	Beijing Sea Heart International Science And Technology Co.,Ltd.	3b34f263-1232-4bb9-e063-6294a90a494d	2026-08-27	Warnings	Exact identifier application number: M032
SMOOTH AND SOFT DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	9e235139-07a2-469a-8601-db69379ce347	2026-08-24	Warnings	Exact identifier application number: M032
ITCHY SCALP RELIEF DANDRUFF	PYRITHIONE ZINC	Universal Distribution Center LLC	634019c2-03a3-4fed-939e-6f9a50ddea7b	2026-08-24	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b4f9e3-c241-6a70-e063-6294a90a364f	2026-08-23	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b52a52-dab0-87b5-e063-6294a90a0596	2026-08-23	Warnings	Exact identifier application number: M032
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b67ce0-3546-c18a-e063-6394a90ae50a	2026-08-23	Warnings	Exact identifier application number: M032
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	599f2cce-0c27-d425-e063-6394a90a1565	2026-08-22	Warnings	Exact identifier application number: M032
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	59a0a062-92d1-210a-e063-6394a90a9bf9	2026-08-22	Warnings	Exact identifier application number: M032
Ouai Anti-Dandruff	SALICYLIC ACID	The Procter & Gamble Manufacturing Company	5990c45f-f653-b403-e063-6394a90a329d	2026-08-21	Warnings	Exact identifier application number: M032
Dermatology Psoriasis Cream	COAL TAR	G.M.J Natural Products, Inc.	96cc5455-f3b8-4ded-a158-5de209d7bf0d	2026-08-21	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R953O2RHZ5	PYRITHIONE ZINC	13463-41-7	PYRITHIONE ZINC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2104634	Head & Shoulders 0.1 % Topical Lotion	PSN	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
1052676	pyrithione zinc 0.1 % Topical Lotion	PSN	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
2104634	zinc pyrithione 1 MG/ML Topical Lotion [Head & Shoulders]	SBD	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
1052676	zinc pyrithione 1 MG/ML Topical Lotion	SCD	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
2104634	Head & Shoulders 0.1 % Topical Lotion	SY	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
2104634	Head & Shoulders 1 MG/ML Topical Lotion	SY	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8
1052676	zinc pyrithione 0.1 % Topical Lotion	SY	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69423-309-12	69423030912	1 BOTTLE, PUMP in 1 CARTON (69423-309-12) / 125 mL in 1 BOTTLE, PUMP		2018-08-30	0000-00-00	No	No	Current
69423-309-50	69423030950	50 mL in 1 BOTTLE, PUMP (69423-309-50)	50 ml	2019-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Head and Shoulders ® Royal Oils Instant Soothe Scalp Elixir	The Procter & Gamble Manufacturing Company	2025-12-18	HUMAN OTC DRUG LABEL	8