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 146 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BODY ACTION PRODUCTS Climax Control Gel BENZOCAINE PRODUCT MAX GROUP INC 53e746cc-0078-4381-bf0b-9c8f98d66904 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Endless Love for Men BENZOCAINE PRODUCT MAX GROUP INC d0fa792d-dc04-4bdf-a22d-dea896beae5b 2023-11-10 Warnings Exact identifier application number: M017 Endless Love For Men BENZOCAINE Body Action Products, Inc 4e89cd3a-ecad-44c3-acb3-6d0810add8c0 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Higher Control Male Climax BENZOCAINE PRODUCT MAX GROUP INC 3c7fa73b-abe8-4a8d-951c-4e785d6e812c 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 65a319a6-89d2-44c9-81d5-30327f9948cb 2023-11-10 Warnings Exact identifier application number: M017 Uber Numb LIDOCAINE HYDROCHLORIDE UBERScientific, LLC 768f3f0e-1add-404f-b869-00a9f35ad34a 2023-11-10 Warnings Exact identifier application number: M017 Zcaine Fast Acting Anesthetic LIDOCAINE PHI, Inc d072243f-6ba6-4ab6-8ebf-a2381fa9c2df 2023-11-09 Warnings Exact identifier application number: M017 Plum Smooth Plumb Numb Gelee LIDOCAINE Universal Companies, Inc. 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e 2023-11-09 Warnings Exact identifier application number: M017 Sonacaine Topical Anesthetic With Menthol LIDOCAINE Filltech USA, LLC ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a 2023-11-09 Warnings Exact identifier application number: M017 Bed Bug Instant Bite Relief LIDOCAINE P.F. Harris Mfg. Co. LLC 7f472fd0-5605-4cc6-b4b2-1267e815255c 2023-11-09 Warnings Exact identifier application number: M017 Valtrum Aerobic Sports SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 33f2491e-c1f2-4e5a-acbe-8ace844b88d6 2023-11-09 Warnings Exact identifier application number: M017 Valtrum Topical Analgesic Roll On SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) LABORATORIOS QUANTIUM LLC 28167e2a-9afb-44e7-90c7-9577df9504b6 2023-11-09 Warnings Exact identifier application number: M017 Satohap Cool Type CAMPHOR, MENTHOL, METHYL SALICYLATE Sato Pharmaceutical Co., Ltd. fe07a00a-2699-44d3-887d-bd068948ad7b 2023-11-07 Warnings Exact identifier application number: M017 Hims Delay Wipes BENZOCAINE WIPES Hims Inc. adbead3d-dca0-4919-b688-44c88f779e5a 2023-11-07 Warnings Exact identifier application number: M017 Bakers Best Maximum Strength Pain Relief LIDOCAINE HYDROCHLORIDE, MENTHOL Baker's Best Health Products, LLC 9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Pain Relief with Pure Hemp Seed Oil LIDOCAINE HYDROCHLORIDE, MENTHOL BAKER'S BEST HEALTH PRODUCTS, INC. ae54c234-bfe4-4a74-b293-db7efda7884b 2023-11-06 Warnings Exact identifier application number: M017 Arth RX Topical Analgesic METHYL NICOTINATE, CAPSAICIN HCD Sales a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609 2023-11-06 Warnings Exact identifier application number: M017 BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender HISTAMINE DIHYDROCHLORIDE BAKER'S BEST HEALTH PRODUCTS, INC. 03ec87c5-6669-4afb-8d9c-c8dc9907495d 2023-11-06 Warnings Exact identifier application number: M017 DOCTORS TOUCH Erase The Pain MENTHOL DOCTOR'S CHOICE MEDICAL, LLC fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0 2023-11-06 Warnings Exact identifier application number: M017 RadiaGuard Advanced Radiation Relief LIDOCAINE HYDROCHLORIDE SMOOTH SIDE, INC 21205087-5a2e-41a5-be40-30cba2895408 2023-11-06 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