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 125 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermacinRx Penetral Cream CAPSAICIN PureTek Corporation 1e343a52-6071-3230-e054-00144ff8d46c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 36abfc2c-d424-4df8-968d-866342c96a56 2024-10-02 Warnings Exact identifier application number: M017 Eagle Balm CAMPHOR MENTHOL Eagle Indo Pharma, PT 87614869-9675-2c76-e053-2a95a90a48a9 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited d9a93daa-4e24-6690-e053-2a95a90a147c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Extra Strength MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited c62a4313-2c07-5f58-e053-2995a90a083a 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT e272ec90-3cd9-5b70-e053-2a95a90a1df4 2024-10-02 Warnings Exact identifier application number: M017 RUGBY HYDROCORTISONE WITH ALOE HYDROCORTISONE A-S Medication Solutions b2674075-aaa4-4c77-bcaa-a76336b3c321 2024-10-02 Warnings Exact identifier application number: M017 Herb Street Anti-Itch Stick HYDROCORTISONE Balassa Laboratories Inc. 8717faae-59c3-4c6f-9ef1-285c0d2445ed 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Backache and Sore Muscle Relief MENTHOL Balassa Laboratories Inc. aeac1b64-8689-4b3d-a41c-db41061257b5 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Arthritis Relief MENTHOL/CAMPHOR Balassa Laboratories Inc. a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 2024-10-01 Warnings Exact identifier application number: M017 Lido King Lidocaine 4% Pain Relieving Gel-Patch LIDOCAINE Galaxy Bio, Inc. 2243734a-4ea2-a5e5-e063-6294a90aba15 2024-10-01 Warnings Exact identifier application number: M017 Medicated Herbal Lip Balm MENTHOL Earth Mama Angel Baby LLC 1cc2391e-6a7a-609c-e063-6394a90a6305 2024-10-01 Warnings Exact identifier application number: M017 CVS Health Lidocaine Plus Pain Relieving LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL NATURAL ESSENTIALS, INC. 1adb9b74-4a01-4461-b845-f3aedcb3f810 2024-10-01 Warnings Exact identifier application number: M017 Circata CAPSAICIN PureTek Corporation b67161d7-cc5c-e971-e053-2995a90acbe7 2024-10-01 Warnings Exact identifier application number: M017 Menticam CAMPHOR,MENTHOL, METHYL SALICYLATE PureTek Corporation ffea2e97-777f-434b-e053-6394a90a3a63 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Sore Muscle Relief METHYL SALICYLATE Balassa Laboratories Inc. e43943c2-d4cd-44c5-a0ff-403a8d42860f 2024-10-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Kroger Company 68dab606-0385-48b7-9a7b-a2cf83d20393 2024-09-29 Warnings Exact identifier application number: M017 kirkland signature hydrocortisone plus maximum strength HYDROCORTISONE Costco Wholesale Company 481341c5-db1f-43fb-aed7-f40495a4eab8 2024-09-29 Warnings Exact identifier application number: M017 Care One hydrocortisone maximum strength HYDROCORTISONE American Sales Company 32593229-d0ac-4d6c-831a-089fc6e76152 2024-09-29 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