Cortizone 10
- Product NDC
- 41167-0039
- 11-digit product format
- 411670039
- Labeler code
- 41167
- Product ID
- 41167-0039_815a6a84-6cc3-4373-bfa2-cbeb96324b98
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- hydrocortisone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Chattem, Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-09-01
- Substance
- HYDROCORTISONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 41167-0039 | 41167-0039-0 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 41167-0039 | 41167-0039-9 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41167-0039-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41167-0039-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41167-0039-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41167-0039-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41167-0039-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41167-0039-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41167-0039-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41167-0039-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41167-0039-9 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41167-0039-9 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41167-0039-9 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41167-0039-9 | ad56d346431e… | cc804d4bbf1e… |
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
- Cortizone 10
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCORTISONE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41167-0039-0 | Cortizone 10 | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0039-0 | Cortizone 10 | 14 g in 1 TUBE | CREAM | 14 | 16 | |
| 41167-0039-1 | Cortizone 10 | 28 g in 1 TUBE | CREAM | 28 | 16 | |
| 41167-0039-1 | Cortizone 10 | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0039-2 | Cortizone 10 | 2 in 1 CASE | CREAM | 2 | 16 | |
| 41167-0039-2 | Cortizone 10 | 56 g in 1 TUBE | CREAM | 56 | 16 | |
| 41167-0039-6 | Cortizone 10 | 56 g in 1 TUBE | CREAM | 56 | 16 | |
| 41167-0039-6 | Cortizone 10 | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0039-9 | Cortizone 10 | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0039-9 | Cortizone 10 | 35 g in 1 TUBE | CREAM | 35 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41167-0039-1 | GM - Gram | 41167-0039 | d94054f4-ec20-40dd-8c12-c0a048878cf0 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41167-0039 | CORTIZONE 10 COOLING RELIEF (HYDROCORTISONE) GEL CORTIZONE 10 (HYDROCORTISONE) CREAM CORTIZONE 10 INTENSIVE HEALING (HYDROCORTISONE) CREAM CORTIZONE 10 (HYDROCORTISONE) OINTMENT CORTIZONE 10 PLUS (HYDROCORTISONE) CREAM [CHATTEM, INC.] | 14 | Current NDC, Legacy NDC, 10 package rows | 20250410_bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ActivICE | MENTHOL | Medline Industries, LP | 834adeb9-38ad-0cfe-e053-2991aa0af82f | 2026-09-01 | Warnings | M017 |
| La Vaquita New Extra | METHYL SALICYLATE, MENTHOL | Delon Laboratories (1990) Ltd | 3097a01b-cee5-492f-b65a-63992fb28e3a | 2026-09-01 | Warnings | M017 |
| Terramed Just Think Comfort Hydrocortisone 1% Cream | HYDROCORTISONE | Rida LLC | 0d2c0c2c-370f-4adb-b0ea-1e218c927f8b | 2026-09-01 | Warnings | M017 |
| Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE | HyVee Inc | 53157137-b980-45d2-aa10-8c111c0ec2f4 | 2026-08-31 | Warnings | M017 |
| EAYONYUMT NECK PAIN RELIEF | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a450e68-07a7-a4bb-e063-6294a90a97c9 | 2026-08-30 | Warnings | M017 |
| EAYONYUM BACK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a458280-4f9c-5af6-e063-6394a90acb2e | 2026-08-30 | Warnings | M017 |
| EAYONYUM KNEE PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 5a45d19f-c753-71eb-e063-6294a90a4805 | 2026-08-30 | Warnings | M017 |
| Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin | HYDROCORTISONE | AmerisourceBergen | c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495 | 2026-08-30 | Warnings | M017 |
| Olu Pain Management | LIDOCAINE AND CAMPHOR | HAWAII REPACK, INC. | 31ed3d82-ba12-46b2-b0ec-7e5e019efc10 | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a177987-7c05-f07f-e063-6394a90aa9ba | 2026-08-28 | Warnings | M017 |
| Relieved Pro Wrap | 4% LIDOCAINE PATCH | Transfer Technology | 5a1c6ebf-ad3f-c47b-e063-6294a90aa19a | 2026-08-28 | Warnings | M017 |
| Sinsinpas Arex Pain Relieving Patch, Medium | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 46453ef2-512b-4852-e063-6394a90a8912 | 2026-08-28 | Warnings | M017 |
| Sinsinpas arex patch large | CAMPHOR, MENTHOL, METHYL SALICYLATE | Sinsin Pharmaceutical Co., Ltd. | 47c242da-56cd-bea1-e063-6394a90a41de | 2026-08-28 | Warnings | M017 |
| 4% Lidocaine Patches | 4% LIDOCAINE PATCHES | Shenzhen Chaoxiji Technology Co.,Ltd. | 5a16c6aa-3ab0-3e46-e063-6294a90a6d8f | 2026-08-27 | Warnings | M017 |
| Lidocaine Patch 4% | LIDOCAINE 4% | Global America Group LLC | 1eec782d-0e56-43d2-b842-da0ae47c5dc9 | 2026-08-26 | Warnings | M017 |
| Careland Lidocaine Plus Menthol Pain Relieving | LIDOCAINE, MENTHOL | Planet (Anhui) Pharmaceutical Co., Ltd | 0f928b5b-60f5-4a45-a409-c601eb330487 | 2026-08-26 | Warnings | M017 |
| PARCHE CALIENTE | CAPSAICINA AND MENTOL | DW SUPPORT LLC | 59f2708e-295a-ccb3-e063-6394a90ad395 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief | LIDOCAINE | CVS Pharmacy | 4ecbc263-e0d4-18d5-e063-6294a90a72e9 | 2026-08-26 | Warnings | M017 |
| CVS Pain Relief Lidocaine XL | LIDOCAINE | CVS Pharmacy | 4aa286e3-e274-8095-e063-6394a90ae871 | 2026-08-26 | Warnings | M017 |
| TERAPIA DE DIA Y NOCHE | PAIN RELIEVING PATCH | DW SUPPORT LLC | 59f44135-865b-9d7d-e063-6294a90a9dd9 | 2026-08-26 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 206352 | Cortizone-10 1 % Topical Cream | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206314 | Cortizone-10 1 % Topical Ointment | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 846161 | Cortizone-10 Cooling Relief 1 % Topical Gel | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 198706 | hydrocortisone 1 % Topical Gel | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 203105 | hydrocortisone 1 % Topical Ointment | PSN | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 846161 | hydrocortisone 0.01 MG/MG Topical Gel [Cortizone] | SBD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206314 | hydrocortisone 0.01 MG/MG Topical Ointment [Cortizone] | SBD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206352 | hydrocortisone 10 MG/ML Topical Cream [Cortizone] | SBD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 198706 | hydrocortisone 0.01 MG/MG Topical Gel | SCD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 203105 | hydrocortisone 0.01 MG/MG Topical Ointment | SCD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 846161 | Cortizone 0.01 MG/MG Topical Gel | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206314 | Cortizone 0.01 MG/MG Topical Ointment | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206352 | Cortizone 1 % Topical Cream | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 846161 | Cortizone 1 % Topical Gel | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206314 | Cortizone 1 % Topical Ointment | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 206352 | Cortizone 10 MG/ML Topical Cream | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 198706 | hydrocortisone 1 % Topical Gel | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 203105 | hydrocortisone 1 % Topical Ointment | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 41167-0039-0 | 41167003900 | 1 TUBE in 1 CARTON (41167-0039-0) > 14 g in 1 TUBE | 1 tube | 2007-09-01 | 0000-00-00 | No | No | Current |
| 41167-0039-1 | 41167003901 | 1 TUBE in 1 CARTON (41167-0039-1) / 28 g in 1 TUBE | 1 tube | 2007-09-01 | 0000-00-00 | No | No | Current |
| 41167-0039-2 | 41167003902 | 2 TUBE in 1 CASE (41167-0039-2) / 56 g in 1 TUBE | 2 tube | 2023-07-01 | No | No | Current | |
| 41167-0039-6 | 41167003906 | 1 TUBE in 1 CARTON (41167-0039-6) / 56 g in 1 TUBE | 1 tube | 2007-09-01 | 0000-00-00 | No | No | Current |
| 41167-0039-9 | 41167003909 | 1 TUBE in 1 CARTON (41167-0039-9) > 35 g in 1 TUBE | 1 tube | 2007-09-01 | 0000-00-00 | No | No | Current |