Home NDC 50580-895 Nizoral
Product NDC 50580-895
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 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N020310-001 NIZORAL ANTI-DANDRUFF 1% SHAMPOO / TOPICAL RLD, RS 1997-10-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020310-001 NIZORAL ANTI-DANDRUFF 1% SHAMPOO / TOPICAL RLD, RS 1997-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020310-001 NIZORAL ANTI-DANDRUFF 1% SHAMPOO / TOPICAL RLD, RS 1997-10-10 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-895-04 50580089504 1 BOTTLE in 1 CARTON (50580-895-04) > 125 mL in 1 BOTTLE 1 bottle 1999-04-01 0000-00-00 No No Current 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 50580-895-14 50580089514 1 BOTTLE in 1 CARTON (50580-895-14) > 125 mL in 1 BOTTLE 1 bottle 1999-04-01 0000-00-00 No No Current 50580-895-15 50580089515 10 PACKET in 1 CARTON (50580-895-15) > 6 mL in 1 PACKET 10 packet 1999-04-01 0000-00-00 No No Current