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 | 2026-08-03 | |
| excluded package | package | 41167-0039 | 41167-0039-9 | D | Discontinued by firm | 2026-08-03 |
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… |
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.
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 |