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 131 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Leader Poison Ivy Wash PRAMOXINE HYDROCHLORIDE LOTION Cardinal Health, 110 dba Leader 81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c 2024-05-13 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Aromatic CAMPHOR, MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited 0e808f89-62dc-3790-e063-6394a90a2351 2024-05-13 Warnings Exact identifier application number: M017 Walgreens Lidocaine Plus Cream BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE Walgreens Company e33e0097-31d6-8083-e053-2a95a90af5d2 2024-05-09 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Pain Relieving Cold Gel CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1794c512-5f42-4ec3-e063-6394a90a87cd 2024-05-03 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro MENTHOL AND CAMPHOR ACTIVE AND INNOVATIVE, LLC 17961a84-6bee-c75f-e063-6394a90af576 2024-05-03 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Pain Relieving Creme LIDOCAINE HYDROCHLORIDE Chattem, Inc. d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd 2024-05-01 Warnings Exact identifier application number: M017 Lidocaine HCl 4 Percent LIDOCAINE HYDROCHLORIDE ARI BRANDS, LLC 81aff5c5-91c0-4173-a432-d20115613580 2024-04-30 Warnings Exact identifier application number: M017 HealthWise 3x Medicated Pain Relief Patch 120 Bulk CAMPHOR,MENTHOL, METHYL SALICYLATE Veridian Healthcare 17545078-05e1-9338-e063-6394a90a678c 2024-04-30 Warnings Exact identifier application number: M017 Professional Therapy MuscleCare Pro Roll-on CAMPHOR, MENTHOL ACTIVE AND INNOVATIVE, LLC 1755ec89-c404-1c17-e063-6394a90ab9fb 2024-04-30 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Roll On MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bc2a14-6bda-428c-e053-2995a90a4ced 2024-04-29 Warnings Exact identifier application number: M017 PAIN RELIEF Gel-Tube MENTHOL Shanghai Chuangshi Medical Technology (Group) Co., Ltd. f0bec1d4-2e18-4519-e053-2a95a90a1bbb 2024-04-29 Warnings Exact identifier application number: M017 THERAPLEX AIM Anti-Itch Moisturizing HYDROCORTISONE THERAPLEX, LLC d1b231b6-cc9f-488a-9121-501831473772 2024-04-27 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE ACETATE JHK Inc dba American Safety & First Aid 64adc8d0-7ca4-4c1a-813f-f1df47e916f2 2024-04-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Plus Cream BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE Veridian Healthcare 16f26249-b508-2c6e-e063-6394a90a265b 2024-04-25 Warnings Exact identifier application number: M017 Hydrocortisone Cream with Aloe HYDROCORTISONE Cardinal Health 110 dba LEADER 16f2f3cb-4611-5867-e063-6394a90af107 2024-04-25 Warnings Exact identifier application number: M017 Burn LIDOCAINE HYDROCHLORIDE JHK Inc 5a4ac4cc-015a-48e7-81f8-93a895049afd 2024-04-25 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief MENTHOL, UNSPECIFIED FORM Walgreen Co. ede15818-5d17-477d-a8be-7b36bb0770a6 2024-04-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE Neilmed Pharmaceuticals Inc. 14b4f066-fde4-ac97-e063-6394a90ae64c 2024-04-20 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relief Patch MENTHOL 5% Walgreens Company e33c90d1-2729-970f-e053-2995a90ad97a 2024-04-18 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Pain Relief Patch MENTHOL Veridian Healthcare 0ce356e0-90a3-ad52-e063-6294a90a404a 2024-04-18 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