Home NDC 51672-3007 Hydrocortisone and Acetic Acid
Product NDC 51672-3007
11-digit product format 516723007
Labeler code 51672
Product ID 51672-3007_395a20ab-856b-3f08-e063-6294a90aa48e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone and Acetic Acid
Dosage form SOLUTION
Route AURICULAR (OTIC)
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA088759
Marketing category ANDA
Marketing start 2005-04-28
Substance HYDROCORTISONE; ACETIC ACID
Active strength 10.4; 20.8 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 A088759-001 HYDROCORTISONE AND ACETIC ACID ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088759-001 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 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT RLD, RS 1985-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088759-001 HYDROCORTISONE AND ACETIC ACID 2%;1% SOLUTION/DROPS / OTIC AT 1985-03-04 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 HYDROCORTISONE 10.4 mg/mL ACETIC ACID 20.8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup Q40Q9N063P Internal UNII 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 51672-3007-1 Hydrocortisone and Acetic Acid 10 mL in 1 BOTTLE SOLUTION 10 6 51672-3007-1 Hydrocortisone and Acetic Acid 1 in 1 CARTON SOLUTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetic Acid ACTIVE INGREDIENT Q40Q9N063P HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Acetic Acid ACTIVE MOIETY Q40Q9N063P HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzethonium chloride INACTIVE INGREDIENT PH41D05744 HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol diacetate INACTIVE INGREDIENT 5Z492UNF9O HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium acetate INACTIVE INGREDIENT 4550K0SC9B HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-3007 HYDROCORTISONE AND ACETIC ACID SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 2 package rows 20250112_6383c722-84e2-4719-a13d-19c54e3eefff.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 Units Marketing start Marketing end Sample Exclude flag Status 51672-3007-1 51672300701 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE 1 bottle 2005-04-28 0000-00-00 No No Current