Head and Shoulders

Product NDC: 37000-095
Requested package NDC: 37000-095-25
11-digit product format: 370000095
Labeler code: 37000
Product ID: 37000-095_4b2042bd-401b-772c-e063-6294a90a8f40
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione Zinc
Dosage form: LOTION/SHAMPOO
Route: TOPICAL
Labeler: The Procter & Gamble Manufacturing Company
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-09-01
Substance: PYRITHIONE ZINC
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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	37000-095	37000-095-25	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Brand name suffix: Smooth and Silky 2in1
Listing expiration: 2027-12-31

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
209884	Internal RxNorm lookup
1043244	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
6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
37000-095-01	Head and ShouldersSmooth and Silky 2in1	930 mL in 1 BOTTLE, PUMP	LOTION/SHAMPOO	930	13
37000-095-01	Head and ShouldersSmooth and Silky 2in1	2 in 1 CELLO PACK	LOTION/SHAMPOO	2	13
37000-095-12	Head and ShouldersSmooth and Silky 2in1	1280 mL in 1 BOTTLE, PUMP	LOTION/SHAMPOO	1280	13
37000-095-13	Head and ShouldersSmooth and Silky 2in1	1280 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	1280	13
37000-095-20	Head and ShouldersSmooth and Silky 2in1	200 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	200	13
37000-095-25	Head and ShouldersSmooth and Silky 2in1	250 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	250	13
37000-095-37	Head and ShouldersSmooth and Silky 2in1	370 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	370	13
37000-095-38	Head and ShouldersSmooth and Silky 2in1	380 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	380	13
37000-095-40	Head and ShouldersSmooth and Silky 2in1	400 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	400	13
37000-095-61	Head and ShouldersSmooth and Silky 2in1	613 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	613	13
37000-095-65	Head and ShouldersSmooth and Silky 2in1	650 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	650	13
37000-095-70	Head and ShouldersSmooth and Silky 2in1	700 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	700	13
37000-095-83	Head and ShouldersSmooth and Silky 2in1	835 mL in 1 BOTTLE, PUMP	LOTION/SHAMPOO	835	13
37000-095-93	Head and ShouldersSmooth and Silky 2in1	930 mL in 1 BOTTLE, PUMP	LOTION/SHAMPOO	930	13
37000-095-95	Head and ShouldersSmooth and Silky 2in1	950 mL in 1 BOTTLE, PUMP	LOTION/SHAMPOO	950	13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pyrithione Zinc	ACTIVE INGREDIENT	R953O2RHZ5	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
Pyrithione Zinc	ACTIVE MOIETY	R953O2RHZ5	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
Coco Monoethanolamide	INACTIVE INGREDIENT	C80684146D	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
glycol distearate	INACTIVE INGREDIENT	13W7MDN21W	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
magnesium carbonate hydroxide	INACTIVE INGREDIENT	YQO029V1L4	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
magnesium sulfate	INACTIVE INGREDIENT	DE08037SAB	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
sodium laureth-3 sulfate	INACTIVE INGREDIENT	BPV390UAP0	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
sodium xylenesulfonate	INACTIVE INGREDIENT	G4LZF950UR	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2
zinc carbonate	INACTIVE INGREDIENT	EQR32Y7H0M	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37000-095	HEAD AND SHOULDERS SMOOTH AND SILKY 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]	11	Current NDC, Legacy NDC, 15 package rows	20250130_6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59.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
1043244	head & shoulders 1 % Medicated Shampoo	PSN	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
1043244	zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]	SBD	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
1043244	Head & Shoulders 1 % Medicated Shampoo	SY	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
1043244	Head & Shoulders 10 MG/ML Medicated Shampoo	SY	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
209884	zinc pyrithione 1 % Medicated Conditioner	SY	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13
209884	zinc pyrithione 1 % Medicated Shampoo	SY	6d1de62a-b1ab-4ae1-8b8d-e9f0b85beb59	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37000-095-25	37000009525	250 mL in 1 BOTTLE, PLASTIC (37000-095-25)	250 ml	2014-12-14	2021-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Head and Shoulders ® Smooth and Silky 2in1	The Procter & Gamble Manufacturing Company	2026-02-18	HUMAN OTC DRUG LABEL	13