Denorex Extra Strength

Product NDC: 62673-059
11-digit product format: 626730059
Labeler code: 62673
Product ID: 62673-059_4ed2043a-0f5e-a764-e063-6394a90aa3bd
Type: HUMAN OTC DRUG
Nonproprietary name: Salicylic Acid
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Neoteric Cosmetics, Inc.
Application: M032
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-06-17
Marketing end: 2029-02-28
Substance: SALICYLIC ACID
Active strength: .03 g/mL
NDC exclude flag: No
Current FDA listing: Yes

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 · 14 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
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62673-059-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62673-059-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62673-059-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62673-059-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62673-059-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62673-059-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62673-059-10	`fb8cb913e6d1…`	`eb8c232b6be0…`

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 Extra Strength

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SALICYLIC ACID	.03 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O414PZ4LPZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
205023	Internal RxNorm lookup
1303358	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
21d234ff-f379-4bcd-9ba0-90f27c6d3a69	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62673-059-10	2024-12-18	C162847	48780-1	e4f33bdf-a537-d8a0-e053-dadaa90a6e4e	Denorex Extra Strength with Conditioner
62673-059-10	2022-07-29	C162847	48780-1	e4f33bdf-a537-d8a0-e053-dadaa90a6e4e	Denorex Extra Strength with Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62673-059-10	Denorex Extra Strength	296 mL in 1 BOTTLE	SHAMPOO	296		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62673-059	DENOREX EXTRA STRENGTH (SALICYLIC ACID) SHAMPOO [NEOTERIC COSMETICS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250523_21d234ff-f379-4bcd-9ba0-90f27c6d3a69.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 20 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaD ATOPIC DERMATITIS Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	d872a4ee-554e-4bca-acb1-3bbf57dc690b	2025-05-29	Warnings	Exact identifier application number: M032
DermaD JOCK ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	c8c0449c-11f9-4434-a91c-b690d6780820	2025-05-29	Warnings	Exact identifier application number: M032
DermaD Psoriasis Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	e52c647b-8cdc-4023-af22-fbfb84ea0ada	2025-05-27	Warnings	Exact identifier application number: M032
DermaER Psoriasis Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	f62e6c5e-6e80-4b75-a0b1-c893224d9ce4	2025-05-27	Warnings	Exact identifier application number: M032
DermaZinc	PYRITHIONE ZINC	WynnPharm Inc	e71e87ba-2a62-44f3-e053-2995a90a8b11	2025-05-25	Warnings	Exact identifier application number: M032
Tagrid ANTI FUNGAL	ZINC PYRITHIONE,SALICYLIC ACID	TAGRID LLC	3376b104-1f07-fab3-e063-6394a90a0ca4	2025-05-22	Warnings	Exact identifier application number: M032
Koi Beauty 5% Minoxidil Hair Growth Serum	5% MINOXIDIL HAIR GROWTH SERUM	Beijing Sea Heart International Science And Technology Co.,Ltd.	358dfbcd-6152-2842-e063-6394a90a2ab4	2025-05-20	Warnings	Exact identifier application number: M032
Coal Tar	COAL TAR	Nopsor USA Distribution Co., Inc.	407bd007-bec6-2864-e054-00144ff88e88	2025-05-05	Warnings	Exact identifier application number: M032
AntiDandruffShampoo	365 ANTI DANDRUFF SHAMPOO	Whole Foods Market, Inc.	b9bc6bbb-31c5-427e-e053-2995a90a5f17	2025-04-29	Warnings	Exact identifier application number: M032
AntiDandruffShampooConditioner	365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1	Whole Foods Market, Inc.	c3f5b5fb-acb0-a904-e053-2995a90a5623	2025-04-29	Warnings	Exact identifier application number: M032
UTTSE Anti Fungal Shampoo.	ANTI FUNGAL SHAMPOO	Shenzhen Xinxin Yunhai Technology Co., Ltd.	33bebbe9-e0ab-2f7d-e063-6294a90add4e	2025-04-27	Warnings	Exact identifier application number: M032
Psalmonica Hair Growth Serum	MINOXIDIL	Guangzhou Haishi Biological Technology Co., Ltd.	3380fe6d-e057-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint	PYRITHIONE ZINC SHAMPOO	China Ningbo Shangge Cosmetics Technology Corp.	3344c97b-8767-3f87-e063-6394a90a4f5d	2025-04-21	Warnings	Exact identifier application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter	PYRITHIONE ZINC SHAMPOO	China Ningbo Shangge Cosmetics Technology Corp.	3346e2c5-af28-74ad-e063-6394a90abbab	2025-04-21	Warnings	Exact identifier application number: M032
Structure of Skin Soothing Anti-Dandruff	PYRITHIONE ZINC	STRUCTURE OF SKIN LLC	3311fa83-a06b-b379-e063-6394a90ae269	2025-04-18	Warnings	Exact identifier application number: M032
LILIVERA Hair Regrowth Kit	MINOXIDIL	Guangzhou Haishi Biological Technology Co., Ltd.	330602da-ec17-5a35-e063-6394a90a741b	2025-04-17	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	3272a482-3813-63e4-e063-6394a90a43eb	2025-04-10	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse for normal hair	PYRITHIONE ZINC	Rejoice International Inc.	b90e574c-933c-4f86-aadc-567ffbe6ea04	2025-04-09	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse for sensitive hair	PYRITHIONE ZINC	Rejoice International Inc.	979394c2-5681-44c8-a43c-bf3a392bd0c1	2025-04-09	Warnings	Exact identifier application number: M032
LEAHUE MADHUCA TONIC	SALICYLIC ACID	Bio-interchange Co.	31ee4645-0f64-f7a0-e063-6394a90a1736	2025-04-04	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1303358	Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012	PSN	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
205023	salicylic acid 3 % Medicated Shampoo	PSN	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
1303358	salicylic acid 30 MG/ML Medicated Shampoo [Denorex Extra Strength Reformulated Aug 2012]	SBD	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
205023	salicylic acid 30 MG/ML Medicated Shampoo	SCD	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
1303358	Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012	SY	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
1303358	Denorex Extra Strength Reformulated Aug 2012 30 MG/ML Medicated Shampoo	SY	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4
205023	salicylic acid 3 % Medicated Shampoo	SY	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62673-059-10	62673005910	296 mL in 1 BOTTLE (62673-059-10)	296 ml	2019-06-17	2029-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Denorex Extra Strength with Conditioner	Neoteric Cosmetics, Inc.	2026-04-01	HUMAN OTC DRUG LABEL	4