Head and Shoulders

Product NDC: 51769-139
11-digit product format: 517690139
Labeler code: 51769
Product ID: 51769-139_bee61e39-5dbe-4dc0-b6bd-d753fe128346
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione Zinc
Dosage form: LOTION/SHAMPOO
Route: TOPICAL
Labeler: ALL NATURAL DYNAMICS
Application: part358H
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-01-29
Marketing end: 0000-00-00
Substance: PYRITHIONE ZINC
Active strength: 0 g/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51769-139		I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-01	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-05	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-11	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-18	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-20	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-40	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-50	I	Inactivated by FDA	2026-10-05
excluded package	package	51769-139	51769-139-70	I	Inactivated by FDA	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 4 · 198 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51769-139-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51769-139-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51769-139-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51769-139-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51769-139-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51769-139-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-139-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-139-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-139-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-139-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51769-139-20	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51769-139-01	Head and Shoulders renewing clean
51769-139-05	Head and Shoulders renewing clean
51769-139-11	Head and Shoulders renewing clean
51769-139-18	Head and Shoulders renewing clean
51769-139-20	Head and Shoulders renewing clean
51769-139-40	Head and Shoulders renewing clean
51769-139-50	Head and Shoulders renewing clean
51769-139-70	Head and Shoulders renewing clean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51769-139-01	Head and Shouldersrenewing clean	10 mL in 1 POUCH	LOTION/SHAMPOO	10	1
51769-139-05	Head and Shouldersrenewing clean	50 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	50	1
51769-139-11	Head and Shouldersrenewing clean	1000 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	1000	1
51769-139-18	Head and Shouldersrenewing clean	1180 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	1180	1
51769-139-20	Head and Shouldersrenewing clean	200 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	200	1
51769-139-40	Head and Shouldersrenewing clean	400 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	400	1
51769-139-50	Head and Shouldersrenewing clean	500 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	500	1
51769-139-70	Head and Shouldersrenewing clean	700 mL in 1 BOTTLE, PLASTIC	LOTION/SHAMPOO	700	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pyrithione Zinc	ACTIVE INGREDIENT	R953O2RHZ5	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
Coco Monoethanolamide	INACTIVE INGREDIENT	C80684146D	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
glycol distearate	INACTIVE INGREDIENT	13W7MDN21W	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)	INACTIVE INGREDIENT	B16G315W7A	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
magnesium carbonate hydroxide	INACTIVE INGREDIENT	YQO029V1L4	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
magnesium sulfate	INACTIVE INGREDIENT	DE08037SAB	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
sodium laureth sulfate	INACTIVE INGREDIENT	BPV390UAP0	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
sodium xylenesulfonate	INACTIVE INGREDIENT	G4LZF950UR	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1
zinc carbonate	INACTIVE INGREDIENT	EQR32Y7H0M	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51769-139	HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]	1	Legacy NDC, 8 package rows	20130130_d5d3eea1-e97d-4d63-9329-35e38ece507a.zip

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	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
1043244	zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]	SBD	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
1043244	Head & Shoulders 1 % Medicated Shampoo	SY	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
1043244	Head & Shoulders 10 MG/ML Medicated Shampoo	SY	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	d5d3eea1-e97d-4d63-9329-35e38ece507a	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	d5d3eea1-e97d-4d63-9329-35e38ece507a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51769-139-01	51769013901	10 mL in 1 POUCH	10 ml	Historical
51769-139-05	51769013905	50 mL in 1 BOTTLE, PLASTIC	50 ml	Historical
51769-139-11	51769013911	1000 mL in 1 BOTTLE, PLASTIC	1000 ml	Historical
51769-139-18	51769013918	1180 mL in 1 BOTTLE, PLASTIC	1180 ml	Historical
51769-139-20	51769013920	200 mL in 1 BOTTLE, PLASTIC	200 ml	Historical
51769-139-40	51769013940	400 mL in 1 BOTTLE, PLASTIC	400 ml	Historical
51769-139-50	51769013950	500 mL in 1 BOTTLE, PLASTIC	500 ml	Historical
51769-139-70	51769013970	700 mL in 1 BOTTLE, PLASTIC	700 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Head and Shoulders renewing clean	ALL NATURAL DYNAMICS \| Procter & Gamble Manufactura, S. de R.L. de C.V.	2013-01-29	HUMAN OTC DRUG LABEL	1