Home NDC 55505-196 Nizoral
Product NDC 55505-196
11-digit product format 555050196
Labeler code 55505
Product ID 55505-196_78acf0f9-ecab-41b3-9319-d67e7ab12a55
Type HUMAN OTC DRUG
Nonproprietary name Ketoconazole
Dosage form SHAMPOO
Route TOPICAL
Labeler Kramer Laboratories
Application NDA020310
Marketing category NDA
Marketing start 2022-06-16
Substance KETOCONAZOLE
Active strength 10 mg/mL
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 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…2022-10-28 04:53 UTC 2022-10 N020310-001 NIZORAL ANTI-DANDRUFF 1% SHAMPOO / TOPICAL RLD, RS 1997-10-10 f41ea6bd6efb…
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 Nizoral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOCONAZOLE 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55505-196 NIZORAL (KETOCONAZOLE) SHAMPOO [KRAMER LABORATORIES] 5 Current NDC, Legacy NDC, 19 package rows 20250101_a17b7424-ee7e-4fcc-b6b3-0904932ae319.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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55505-196-33 55505019633 1 BOTTLE in 1 CARTON (55505-196-33) / 125 mL in 1 BOTTLE 1 bottle 2022-06-16 0000-00-00 No No Current 55505-196-40 55505019640 1 BOTTLE in 1 CARTON (55505-196-40) / 200 mL in 1 BOTTLE 1 bottle 2022-06-16 0000-00-00 No No Current 55505-196-47 55505019647 4 mL in 1 PACKET (55505-196-47) 4 ml 2024-03-01 No No Current 55505-196-57 55505019657 2 BOTTLE in 1 CARTON (55505-196-57) / 200 mL in 1 BOTTLE 2 bottle 2023-04-29 No No Current 55505-196-64 55505019664 1 BOTTLE in 1 CARTON (55505-196-64) > 325 mL in 1 BOTTLE 1 bottle 2022-06-16 0000-00-00 No No Current 55505-196-65 55505019665 1 CARTON in 1 CARTON (55505-196-65) / 400 mL in 1 CARTON 1 carton 2022-06-16 0000-00-00 No No Current 55505-196-68 55505019668 3 BOTTLE in 1 CARTON (55505-196-68) / 200 mL in 1 BOTTLE 3 bottle 2022-10-15 No No Current 55505-196-72 55505019672 2 BOTTLE in 1 CARTON (55505-196-72) / 325 mL in 1 BOTTLE 2 bottle 2023-12-01 No No Current 55505-196-84 55505019684 2 BOTTLE in 1 CARTON (55505-196-84) / 400 mL in 1 BOTTLE 2 bottle 2025-06-01 No No Current 55505-196-85 55505019685 1 BOTTLE in 1 CARTON (55505-196-85) / 562 mL in 1 BOTTLE 1 bottle 2026-01-12 No No Current