Denorex Severe Flakes

Product NDC: 62673-176
11-digit product format: 626730176
Labeler code: 62673
Product ID: 62673-176_41ad0d3a-0705-44c9-e063-6394a90ad40d
Type: HUMAN OTC DRUG
Nonproprietary name: Pyrithione Zinc
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Neoteric Cosmetics, Inc.
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-01-01
Substance: ZINC PYRITHIONE
Active strength: .02 g/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Denorex Severe Flakes
Brand name suffix: Medicated Anti Dandruff
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC PYRITHIONE	.02 g/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
244458	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
41ad0d3a-0704-44c9-e063-6394a90ad40d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62673-176-10	Denorex Severe FlakesMedicated Anti Dandruff	296 mL in 1 BOTTLE	SHAMPOO	296		1
62673-176-10	Denorex Severe FlakesMedicated Anti Dandruff	1 in 1 CARTON	SHAMPOO	1		1

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 14 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders Itchy Scalp 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	157c3f81-f37e-4dab-b724-50fe0d9e1a26	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Conditioner Smooth and Silky	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	41709710-539c-3119-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Care Hair and Scalp Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	42620236-17ef-5c70-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Hair and Scalp Conditioner Green Apple	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	4534c7a7-bc4b-3851-e054-00144ff88e88	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Old Spice Pure Sport	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7bbfc667-bf9b-08c2-e053-2a91aa0a8009	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Royal Oils Daily Moisture Scalp	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7b1f81e1-1fee-5be2-e053-2a91aa0aa063	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Royal Oils Instant Soothe Scalp	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7b20f226-3b0a-2ae5-e053-2a91aa0a2f5a	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Coconut Daily Hair and Scalp Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7cc10c1b-fe0b-7d4c-e053-2a91aa0a2377	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Men Advanced Series Swagger Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3cdf44-ae1d-fed5-e053-2a91aa0a3021	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Detox and Hydrate	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	8659218e-cb8d-bb44-e053-2a91aa0ae37b	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Soothe and Strengthen	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86972263-dcef-358f-e053-2991aa0a734f	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Color Protect	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	8697a03b-7050-3a49-e053-2a91aa0a7271	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Detox and Hydrate Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86ab72bc-4e9d-0075-e053-2a91aa0a1135	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Soothe and Strengthen Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86abfdc2-d55b-4adb-e053-2991aa0a54b1	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Advanced Series Bourbon 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	98480eaa-6798-4efe-e053-2a95a90a869f	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders MEN Advanced Series Sandalwood 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	9858f681-1aca-e481-e053-2a95a90a869d	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Apple Cider Vinegar 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	b698b310-a794-e7f3-e053-2a95a90a47c4	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Dandruff Defense Dry Scalp Rescue	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	c7bc3942-6943-2ea5-e053-2a95a90a42a9	2025-12-18	Warnings	Exact identifier application number: M032
Royal Oils by head and shoulders Moisture Renewal Scalp Balancing Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	c95e82e4-74fb-9dbf-e053-2a95a90a93e5	2025-12-18	Warnings	Exact identifier application number: M032
Head and Shoulders Moisturizing Avocado Oil	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	d08969cb-24ca-c49c-e053-2a95a90a71d1	2025-12-18	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
244458	zinc pyrithione 2 % Medicated Shampoo	PSN	41ad0d3a-0704-44c9-e063-6394a90ad40d	1
244458	zinc pyrithione 20 MG/ML Medicated Shampoo	SCD	41ad0d3a-0704-44c9-e063-6394a90ad40d	1
244458	zinc pyrithione 2 % Medicated Shampoo	SY	41ad0d3a-0704-44c9-e063-6394a90ad40d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62673-176-10	62673017610	1 BOTTLE in 1 CARTON (62673-176-10) / 296 mL in 1 BOTTLE	1 bottle	2026-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Denorex Severe Flakes Medicated Anti Dandruff	Neoteric Cosmetics, Inc.	2025-10-21	HUMAN OTC DRUG LABEL	1