Nizoral

Product NDC: 50580-895
Requested package NDC: 50580-895-07
11-digit product format: 505800895
Labeler code: 50580
Product ID: 50580-895_490715fc-184d-4fcf-9e27-4209db5d18da
Type: HUMAN OTC DRUG
Nonproprietary name: Ketoconazole
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application: NDA020310
Marketing category: NDA
Marketing start: 1999-04-01
Marketing end: 0000-00-00
Substance: KETOCONAZOLE
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50580-895	50580-895-07	D	Discontinued by firm		2026-08-17

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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020310-001	NIZORAL ANTI-DANDRUFF	KETOCONAZOLE	1%	SHAMPOO / TOPICAL		RLD, RS	1997-10-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020310-001	NIZORAL A-D	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020310-001	NIZORAL ANTI-DANDRUFF	1%	SHAMPOO / TOPICAL	RLD, RS	1997-10-10	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50580-895-04	2021-09-24	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-07	2021-09-24	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-14	2021-09-24	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-15	2021-09-24	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-04	2021-07-23	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-07	2021-07-23	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-14	2021-07-23	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%
50580-895-15	2021-07-23	Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-895-04	ML - Milliliter	50580-895	de28f2d0-5696-4fbe-89b1-5ba91cc062e9	1	2012-07-24
50580-895-07	ML - Milliliter	50580-895	0cd4993d-fb10-4ff7-9129-1e5d50d8d4e1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
carbomer 1342	INACTIVE INGREDIENT	809Y72KV36	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Coco Monoethanolamide	INACTIVE INGREDIENT	C80684146D	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
FD&C Blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Glycol Distearate	INACTIVE INGREDIENT	13W7MDN21W	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Quaternium-15	INACTIVE INGREDIENT	E40U03LEM0	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	NIZORAL (KETOCONAZOLE) SHAMPOO [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nizoral	KETOCONAZOLE	Kramer Laboratories	a17b7424-ee7e-4fcc-b6b3-0904932ae319	2026-03-17	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310
Nizoral	KETOCONAZOLE	Kramer Laboratories	f5c8c5b4-49bd-4dc7-8c29-8f1317c6ef88	2025-08-21	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310
Nizoral	KETOCONAZOLE	Kramer Laboratories	8dd6b2f1-f438-4be1-a6c4-4f6c8902dfb6	2025-07-11	Warnings	Exact identifier application applno (NDA): 020310 application number: NDA020310

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R9400W927I	KETOCONAZOLE	65277-42-1	KETOCONAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-895-07	50580089507	1 BOTTLE in 1 CARTON (50580-895-07) > 200 mL in 1 BOTTLE	1 bottle	1999-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nizoral ® A-D KETOCONAZOLE SHAMPOO 1%	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	2019-12-05	HUMAN OTC DRUG LABEL	4