Home NDC 0713-0678 Nystatin
Product NDC 0713-0678
11-digit product format 007130678
Labeler code 0713
Product ID 0713-0678_ee0cb97f-1642-0dc0-e053-2995a90a8db3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin Cream
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA061966
Marketing category ANDA
Marketing start 2015-04-01
Substance NYSTATIN
Active strength 100000 [USP'U]/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [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 42 .
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 A061966-001 NYSTATIN NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A061966-001 AT
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 · 42 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 2026-08-18 06:07:40 2026-07 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A061966-001 NYSTATIN 100,000 UNITS/GM CREAM / TOPICAL AT Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nystatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0678-15 Nystatin 1 in 1 CARTON CREAM 1 7 0713-0678-15 Nystatin 15 g in 1 TUBE CREAM 15 7 0713-0678-31 Nystatin 30 g in 1 TUBE CREAM 30 7 0713-0678-31 Nystatin 1 in 1 CARTON CREAM 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Algeldrate INACTIVE INGREDIENT 03J11K103C NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Ceteareth-15 INACTIVE INGREDIENT 867H4YOZ8Z NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Sorbitol INACTIVE INGREDIENT 506T60A25R NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN (NYSTATIN CREAM) CREAM [G&W LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0678 NYSTATIN (NYSTATIN CREAM) CREAM [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 4 package rows 20221123_ec1b52af-d38e-eba1-e63c-dba4341d3af2.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 · 5 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 543546 nystatin 100,000 UNT/GM Topical Cream PSN a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100000 UNT/ML Topical Cream SCD a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100,000 UNT/GM Topical Cream SY a1b5ccb2-d0d6-46cc-b792-6920b50d0a03 10 543546 nystatin 100,000 UNT/GM Topical Cream PSN ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100000 UNT/ML Topical Cream SCD ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100,000 UNT/GM Topical Cream SY ec1b52af-d38e-eba1-e63c-dba4341d3af2 7 543546 nystatin 100,000 UNT/GM Topical Cream PSN 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100,000 UNT/GM Topical Cream PSN 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100000 UNT/ML Topical Cream SCD b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100000 UNT/ML Topical Cream SCD da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1 543546 nystatin 100000 UNT/ML Topical Cream SCD 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 42f21220-c68a-d748-e063-6394a90a1e2f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY b1efcc2c-f71a-463d-9a02-fad7550f31ec 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 92ab6d9a-f639-226a-e053-2a95a90a731f 1 543546 nystatin 100,000 UNT/GM Topical Cream SY da44d87a-159e-24d4-e053-2a95a90a09d9 1 543546 nystatin 100,000 UNT/GM Topical Cream SY 98bd8ccb-0c68-47b9-bcb4-c5d8217868d9 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0678-15 00713067815 1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE 1 tube 2015-04-01 0000-00-00 No No Current 0713-0678-31 00713067831 1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE 1 tube 2015-04-01 0000-00-00 No No Current