Home NDC 0713-0849 hydrocortisone and acetic acid
Product NDC 0713-0849
11-digit product format 007130849
Labeler code 0713
Product ID 0713-0849_106bf241-c85e-8985-e063-6394a90abffb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone and acetic acid
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA040609
Marketing category ANDA
Marketing start 2024-02-01
Substance ACETIC ACID; HYDROCORTISONE
Active strength 20; 10 mg/mL; mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A040609-001 HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040609-001 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 · 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 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC 2006-02-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC 2006-02-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC 2006-02-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC 2006-02-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040609-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 2006-02-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 hydrocortisone and acetic acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETIC ACID 20 mg/mL HYDROCORTISONE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q40Q9N063P Internal UNII lookup WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313786 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 0713-0849-09 hydrocortisone and acetic acid 1 in 1 CARTON SOLUTION 1 1 0713-0849-09 hydrocortisone and acetic acid 10 mL in 1 BOTTLE SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0849 HYDROCORTISONE AND ACETIC ACID SOLUTION [COSETTE PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20240203_cef3713f-11f3-4723-9267-3d79855b49bf.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 Units Marketing start Sample Exclude flag Status 0713-0849-09 00713084909 1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE 1 bottle 2024-02-01 No No Current