KeraCare Dry and Itchy Scalp Anti-Dandruff

Product NDC: 63766-003
11-digit product format: 637660003
Labeler code: 63766
Product ID: 63766-003_2413c5d7-f318-5d86-e063-6294a90ac993
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione Zinc
Dosage form: LOTION
Route: TOPICAL
Labeler: Avlon Industries, Inc.
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-18
Marketing end: 2027-05-23
Substance: PYRITHIONE ZINC
Active strength: 10 mg/mL
NDC exclude flag: No
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	63766-003	63766-003-03	D	Discontinued by firm		2026-10-15

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 · 10 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…`

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: KeraCare Dry and Itchy Scalp Anti-Dandruff

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRITHIONE ZINC	10 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
209884	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
5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63766-003-01	2024-02-29	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner
63766-003-02	2024-02-29	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner
63766-003-03	2024-02-29	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner
63766-003-01	2024-01-30	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner
63766-003-02	2024-01-30	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner
63766-003-03	2024-01-30	KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63766-003-01	KeraCare Dry and Itchy Scalp Anti-Dandruff	240 mL in 1 TUBE	LOTION	240	7
63766-003-02	KeraCare Dry and Itchy Scalp Anti-Dandruff	950 mL in 1 BOTTLE	LOTION	950	7
63766-003-03	KeraCare Dry and Itchy Scalp Anti-Dandruff	15 mL in 1 POUCH	LOTION	15	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pyrithione Zinc	ACTIVE INGREDIENT	R953O2RHZ5	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
Pyrithione Zinc	ACTIVE MOIETY	R953O2RHZ5	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
.ALPHA.-HEXYLCINNAMALDEHYDE	INACTIVE INGREDIENT	7X6O37OK2I	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
BENZYL SALICYLATE	INACTIVE INGREDIENT	WAO5MNK9TU	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
DICETYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	6F4SX2007N	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
MAGNESIUM CITRATE	INACTIVE INGREDIENT	RHO26O1T9V	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
PADIMATE O	INACTIVE INGREDIENT	Z11006CMUZ	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
PEG-40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
POLYACRYLAMIDE (1500 MW)	INACTIVE INGREDIENT	5D6TC4BRWV	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
POLYQUATERNIUM-10 (125 MPA.S AT 2%)	INACTIVE INGREDIENT	L45WU8S981	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
POLYQUATERNIUM-32 (30000 MPA.S AT 2%)	INACTIVE INGREDIENT	2KSE7HSH3S	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
STEARALKONIUM CHLORIDE	INACTIVE INGREDIENT	0OUO26BB88	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION/SHAMPOO [AVLON INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63766-003	KERACARE DRY AND ITCHY SCALP ANTI-DANDRUFF (PYRITHIONE ZINC) LOTION [AVLON INDUSTRIES, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20241012_5d501ba0-a6f9-4f0d-86d5-0e8d9302737f.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 18 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief Serum	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	402e2561-e309-46f2-e063-6394a90a4e58	2025-10-02	Warnings	Exact identifier application number: M032
J1002902 Jason Dandruff Relief 2in1 Treatment	PYRITHIONE ZINC	The Hain Celestial Group Inc	8c631014-3832-78cb-e053-2995a90a8d22	2025-10-01	Warnings	Exact identifier application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	40001edd-d98c-4e2a-e063-6394a90a9911	2025-09-30	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Complete Hydration 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	3f66839a-0d8f-e476-e063-6294a90a547c	2025-09-22	Warnings	Exact identifier application number: M032
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	1eae27bc-1b18-ae5d-e063-6394a90a4610	2025-09-12	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ad107b-024b-828f-e053-2995a90aae36	2025-09-04	Warnings	Exact identifier application number: M032
Hermon Folliculitis Shampoo.	SALICYLIC ACID 2%	Beautivity LLC	3c5f7caa-a4af-2574-e063-6394a90a7507	2025-08-14	Warnings	Exact identifier application number: M032
Pert 2 in 1 Advanced plus	SALICYLIC ACID	Sodalis USA, LLC	0eaed46c-ae6f-0d58-e063-6394a90ad2a3	2025-08-13	Warnings	Exact identifier application number: M032
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar	PYRITHIONE ZINC 2%	RoyceDerm LLC	3b98a83d-9c3b-9522-e063-6294a90a7033	2025-08-05	Warnings	Exact identifier application number: M032
Earthmed FS Psoriasis relief	SALICYLIC ACID	Earthmed LLC	3ba584bc-f40a-ce0a-e063-6394a90aebf7	2025-08-05	Warnings	Exact identifier application number: M032
Pert 2 in 1 Extra Strength	SALICYLIC ACID	Sodalis USA, LLC	25c8a46c-4400-709f-e063-6394a90a3f31	2025-07-30	Warnings	Exact identifier application number: M032
anti-fungal	ANTI-FUNGAL SHAMPOO	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	3b102d15-f2ce-5727-e063-6294a90a23a9	2025-07-29	Warnings	Exact identifier application number: M032
Earthmed Sport Anti itch and eczema relief	SALICYLIC ACID	Earthmed LLC	3b14913b-3aab-9dd0-e063-6394a90a3b7f	2025-07-29	Warnings	Exact identifier application number: M032
Soothing psoriasis and eczema relief	SALICYLIC ACID	Carolina Cannabis Creations L.L.C	2bcad94d-1918-7f37-e063-6294a90a4744	2025-07-29	Warnings	Exact identifier application number: M032
DANDRX ANTI-DANDRUFF	ZINC PYRITHIONE	dandRX LLC	399fb507-2263-962f-e063-6394a90ae9a8	2025-07-10	Warnings	Exact identifier application number: M032
anti-dandruff	ANTI-DANDRUFF SHAMPOO	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	3979fb80-8091-c79e-e063-6394a90ae618	2025-07-09	Warnings	Exact identifier application number: M032
CeraVe 2 in 1 Anti-Dandruff Hydrating Conditioner	PYRITHIONE ZINC	LOreal USA Products Inc	7f5ff142-15cb-44be-aa0e-ccd06de23300	2025-07-08	Warnings	Exact identifier application number: M032
5% Minoxidil and 5% Rosemary for Hair Care	MINOXIDIL	TIKNOW LLC	1bb386d2-70c6-c487-e063-6294a90a19da	2025-07-07	Warnings	Exact identifier application number: M032
Red Scalpfixer Anti Dandruff	PYRINTHIONE ZINC	Orange Lab, Inc	386c83c3-8d23-b3b0-e063-6394a90a27ee	2025-07-01	Warnings	Exact identifier application number: M032
Dermabon Multi Symptom Psoriasis Control	COAL TAR	Dermabon de Chihuahua, S.A. de C.V.	d5b739ba-e332-41f6-9343-6ad5cc981344	2025-07-01	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
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	7
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	7
209884	zinc pyrithione 1 % Medicated Conditioner	SY	5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	7
209884	zinc pyrithione 1 % Medicated Shampoo	SY	5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63766-003-01	63766000301	240 mL in 1 TUBE (63766-003-01)	240 ml	2009-06-18	2027-04-08	No	No	Current
63766-003-02	63766000302	950 mL in 1 BOTTLE (63766-003-02)	950 ml	2009-06-18	2027-05-23	No	No	Current
63766-003-03	63766000303	15 mL in 1 POUCH (63766-003-03)	15 ml	2009-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner	Avlon Industries, Inc.	2024-10-09	HUMAN OTC DRUG LABEL	7