Home NDC 69842-988 Miconazole 7
Product NDC 69842-988
11-digit product format 698420988
Labeler code 69842
Product ID 69842-988_362a5224-f51c-e0fc-e063-6394a90ad176
Type HUMAN OTC DRUG
Nonproprietary name Miconazole Nitrate
Dosage form CREAM
Route VAGINAL
Labeler CVS Pharmacy
Application ANDA074444
Marketing category ANDA
Marketing start 1997-01-13
Substance MICONAZOLE NITRATE
Active strength 20 mg/100g
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 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 A074444-001 MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13
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 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074444-001 MICONAZOLE NITRATE 2% CREAM / VAGINAL 1997-01-13 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 Miconazole 7
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 20 mg/100g
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 69842-988-07 Miconazole 7 45 g in 1 TUBE, WITH APPLICATOR CREAM 45 7 69842-988-07 Miconazole 7 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-988 MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [CVS PHARMACY] 7 Current NDC, Legacy NDC, 2 package rows 20250529_5e7e4cf8-24ec-486e-9389-546ffea004d0.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69842-988-07 69842098807 1 TUBE, WITH APPLICATOR in 1 CARTON (69842-988-07) / 45 g in 1 TUBE, WITH APPLICATOR 2016-12-15 0000-00-00 No No Current