Home NDC 51672-2069 Hydrocortisone Acetate
Product NDC 51672-2069
11-digit product format 516722069
Labeler code 51672
Product ID 51672-2069_5ec1ab72-2672-170f-e063-6294a90a040e
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-06-01
Substance HYDROCORTISONE ACETATE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-2069-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51672-2069-9 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51672-2069-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51672-2069-9 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51672-2069-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51672-2069-9 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51672-2069-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51672-2069-9 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51672-2069-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51672-2069-9 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51672-2069-9 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51672-2069-2 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51672-2069-9 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51672-2069-2 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51672-2069-9 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51672-2069-2 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Acetate
Brand name suffix Antipruritic (Anti-Itch)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 1 g/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 51672-2069-2 Hydrocortisone Acetate Antipruritic (Anti-Itch) 28.4 g in 1 TUBE CREAM 28.4 9 51672-2069-2 Hydrocortisone Acetate Antipruritic (Anti-Itch) 1 in 1 CARTON CREAM 1 9 51672-2069-9 Hydrocortisone Acetate Antipruritic (Anti-Itch) 454 g in 1 JAR CREAM 454 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2069 HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH) (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 3 package rows 20230401_9f0b09e7-6cfd-4fd6-8631-67799edf4e08.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 138 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PERSONAL CARE ICE COLD MENTHOL NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 1994356c-e347-5b7d-e063-6394a90a476c 2024-01-01 Warnings Exact identifier application number: M017 Dendracin Neurodendraxcin METHYL SALICYLATE, MENTHOL AND CAPSAICIN Proficient Rx LP 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 2024-01-01 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc c6a0880e-fc16-46e9-8314-c56c9d15bf31 2023-12-31 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Anti Itch HYDROCORTISONE L'Oreal USA Products Inc. 8d65e945-2557-486f-9279-ecbaa08f31c4 2023-12-31 Warnings Exact identifier application number: M017 Nighttime Sleep-Aid Non-Habit Forming DIPHENHYDRAMINE HCI AptaPharma Inc. ed0ba7aa-e794-43da-b576-6b9945bf7477 2023-12-30 Warnings Exact identifier application number: M017 Sting-Kill BENZOCAINE AND MENTHOL RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 2023-12-29 Warnings Exact identifier application number: M017 Maybelline New York Baby Lips Dr Rescue Medicated Balm MENTHOL L'Oreal USA Products Inc 2f7b8221-66f6-4aed-8359-318cfc656a72 2023-12-28 Warnings Exact identifier application number: M017 Equate Cortisone HYDROCORTISONE 1% Walmart Inc 027fae33-93a0-a61f-e063-6294a90a990f 2023-12-27 Warnings Exact identifier application number: M017 Walgreens Cool n Heat Lidocaine LIDOCAINE HCL 4% Walgreens Co 0681c6c5-5a8b-ea9e-e063-6394a90a83bc 2023-12-27 Warnings Exact identifier application number: M017 EXTRA STRENGTH WAL-DRYL ITCH RELIEF DIPHENHYDRAMINE, ZINC ACETATE WALGREEN CO 681cf1af-2cc3-4e6d-b76f-f00731ea3e12 2023-12-27 Warnings Exact identifier application number: M017 XRay Pain Relief MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE Genomma Lab USA 5244ddee-fd9e-4df3-8fb3-b16aa321a316 2023-12-27 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Pharma Nobis, LLC e42fbe63-b01c-4f85-e053-2a95a90a5143 2023-12-26 Warnings Exact identifier application number: M017 Equate Calaspray PRAMOXINE HCL 1%, ZINC ACETATE 0.1% Walmart Inc 027ed5ab-05ec-569f-e063-6394a90abbc3 2023-12-26 Warnings Exact identifier application number: M017 EXTERNAL ANALGESIC CAMPHOR, CAPSICUM, MENTHOL Hmong 21 3b6155a5-51aa-2780-e054-00144ff8d46c 2023-12-26 Warnings Exact identifier application number: M017 LEADER Camphor Spirit CAMPHOR (NATURAL) Cardinal Health, 110 dba Leader 7d3b0b28-5190-0622-e053-2991aa0af561 2023-12-22 Warnings Exact identifier application number: M017 Antiseptic Instant Pain Relief CAMPHOR 10.8% AND PHENOL 4.7% Pharma Nobis, LLC e42f484d-a642-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Itch Relief Gel ITCH RELIEF GEL Pharma Nobis, LLC e42f484d-a641-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Witch Hazel WITCH HAZEL Pharma Nobis, LLC e42f484d-a644-3489-e053-2a95a90a4254 2023-12-22 Warnings Exact identifier application number: M017 Dermoplast Pain relieving BENZOCAINE, MENTHOL Advantice Health dad00c95-4e11-3eec-e053-2a95a90a7a18 2023-12-21 Warnings Exact identifier application number: M017 equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-2069-2 51672206902 1 TUBE in 1 CARTON (51672-2069-2) / 28.4 g in 1 TUBE 1 tube 2001-06-01 0000-00-00 No No Current 51672-2069-9 51672206909 454 g in 1 JAR (51672-2069-9) 454 g 2001-06-01 0000-00-00 No No Current