Home NDC 63736-015 Monistat 3
Product NDC 63736-015
11-digit product format 637360015
Labeler code 63736
Product ID 63736-015_09cb5f1c-b40a-426f-94d0-ec18662feb0f
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route VAGINAL
Labeler Insight Pharmaceuticals LLC
Application NDA020827
Marketing category NDA
Marketing start 1998-03-30
Substance MICONAZOLE NITRATE
Active strength 40 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N020827-001 MONISTAT 3 MICONAZOLE NITRATE 4% CREAM / VAGINAL RLD, RS 1998-03-30
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020827-001 MONISTAT 3 4% CREAM / VAGINAL RLD, RS 1998-03-30 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Monistat 3
Brand name suffix 3 Day
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998544 Internal RxNorm lookup 998546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63736-015-18 Monistat 33 Day 3 in 1 CARTON CREAM 3 7 63736-015-18 Monistat 33 Day 5 g in 1 TUBE, WITH APPLICATOR CREAM 5 7 63736-015-25 Monistat 33 Day 1 in 1 CARTON CREAM 1 7 63736-015-25 Monistat 33 Day 25 g in 1 TUBE, WITH APPLICATOR CREAM 25 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63736-015 MONISTAT 3 3 DAY (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 4 package rows 20241109_f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63736-015-18 63736001518 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR 1998-03-30 0000-00-00 No No Current 63736-015-25 63736001525 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR 1998-03-30 No No Current