Home NDC 51672-2069 Hydrocortisone Acetate
Product NDC 51672-2069
11-digit product format 516722069
Labeler code 51672
Product ID 51672-2069_44fe37d6-007d-8b3b-e063-6394a90ac802
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 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 53 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE LIDOCAINE HYDROCHLORIDE AND MENTHOL, KOBAYASHI Healthcare International, Inc. e364ff83-4aaf-4897-a7da-06581bc321f2 2025-12-18 Warnings Exact identifier application number: M017 Tiger Balm White Regular Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f406161e-a9c4-47d1-8b21-93b1b7938063 2025-12-17 Warnings Exact identifier application number: M017 Resinol PETROLATUM AND RESORCINOL ResiCal, Inc. 03f57a4a-f94b-4ba6-b709-41cfb6e16261 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Maximum Pain Relief LIDOCAINE Veridian Healthcare afc3c16d-0076-44b2-ae7e-5f36d4d8088e 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Max Lidocaine plus Menthol LIDOCAINE, MENTHOL Veridian Healthcare f39a27da-6799-4fc6-97ca-101eac4a9360 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Original Menthol MENTHOL Veridian Healthcare e4bfb6b0-545e-4fbc-8538-4f41a6be1025 2025-12-17 Warnings Exact identifier application number: M017 Welly Polka First Aid Kit HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Dongguan Shenglian Tins Products Co., Ltd. d7c4314c-c4c6-4adf-b384-3ac7a7108319 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Theragesic METHYL SALICYLATE Mission Pharmacal Company db6c0c77-0a20-d574-a98f-e6c9998b941f 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 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