Cortizone 10 Intensive Healing
- Product NDC
- 41167-0035
- 11-digit product format
- 411670035
- Labeler code
- 41167
- Product ID
- 41167-0035_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
- 2007-12-01
- 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 | 41167-0035 | 41167-0035-2 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 41167-0035 | 41167-0035-3 | D | Discontinued by firm | 2026-10-23 |
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 | 41167-0035-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 41167-0035-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 41167-0035-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 41167-0035-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 41167-0035-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 41167-0035-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 41167-0035-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 41167-0035-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 41167-0035-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 41167-0035-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 41167-0035-2 | 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 Intensive Healing
- 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 |
|---|---|---|---|---|---|---|
| 41167-0035-0 | Cortizone 10 Intensive Healing | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0035-0 | Cortizone 10 Intensive Healing | 28 g in 1 TUBE | CREAM | 28 | 16 | |
| 41167-0035-1 | Cortizone 10 Intensive Healing | 56 g in 1 TUBE | CREAM | 56 | 16 | |
| 41167-0035-1 | Cortizone 10 Intensive Healing | 2 in 1 CARTON | CREAM | 2 | 16 | |
| 41167-0035-2 | Cortizone 10 Intensive Healing | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0035-2 | Cortizone 10 Intensive Healing | 35 g in 1 TUBE | CREAM | 35 | 16 | |
| 41167-0035-3 | Cortizone 10 Intensive Healing | 1 in 1 CARTON | CREAM | 1 | 16 | |
| 41167-0035-3 | Cortizone 10 Intensive Healing | 56 g in 1 TUBE | CREAM | 56 | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41167-0035 | 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, 8 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 |
|---|---|---|---|---|---|---|
| PAINGEL UNGUENTO | CAMPHOR, MENTHOL | NACOR BUSINESS GROUP LLC | 42fab525-b0a5-97fb-e063-6394a90aec6c | 2025-11-06 | Warnings | M017 |
| PAINGEL ROLL-ON | MENTHOL | NACOR BUSINESS GROUP LLC | 42fb0bdf-8bbd-bbe3-e063-6294a90a656c | 2025-11-06 | Warnings | M017 |
| Coolexa | CAMPHOR, MENTHOL, METHYL SALICYLATE | Rising Pharma Holdings, Inc. | 38839f29-d4ce-4684-a3c7-0bb4bf1ad594 | 2025-11-06 | Warnings | M017 |
| ItchZap | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Rising Pharma Holdings, Inc. | 245d0afb-19a8-4cfb-968b-d892b18d5f2c | 2025-11-06 | Warnings | M017 |
| Pain Relief Gel-Roll On | LIDOCAINE AND MENTHOL | Bullet point LLC | 42c70681-494b-47c9-e063-6394a90a80be | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | ba6c7e97-d740-484b-8711-55fa7ab15784 | 2025-11-04 | Warnings | M017 |
| China-Gel | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, Inc. | d7c5cb17-f7a2-7f57-e053-2995a90a40f7 | 2025-11-04 | Warnings | M017 |
| Aulief Topical Pain Reliever | MENTHOL AND CAMOHOR | China-Gel, LLC | 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 | 2025-11-04 | Warnings | M017 |
| China-Gel Topical Pain Reliever | MENTHOL AND CAMOHOR (SYNTHETIC) | China-Gel, LLC | 254abae9-ef1b-5a90-e054-00144ff88e88 | 2025-11-04 | Warnings | M017 |
| Pain Relief Gel-Tube | MENTHOL | Bullet point LLC | 42c93789-9758-54b7-e063-6394a90ac398 | 2025-11-04 | Warnings | M017 |
| Tattoo care | TATTOO CARE CREAM | Perfso (HK) Co., Limited | 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 | 2025-11-04 | Warnings | M017 |
| CORE RELIEF | CAMPHOR, MENTHOL | Copper Joint, LLC | 42d17270-f58d-9d69-e063-6294a90a4078 | 2025-11-04 | Warnings | M017 |
| Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Marcella Health | d25f25ee-79f8-49e7-9715-0aae305b73e5 | 2025-11-03 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS NO TOUCH SPRAY | Premier Brands of America Inc. | 36481d67-2346-470b-e063-6294a90aae99 | 2025-11-03 | Warnings | M017 |
| Lidocaine Numbing Cream | LIDOCAINE 5% | YYBA Corp | 1319ee69-8b3f-5815-e063-6294a90a5ad5 | 2025-11-03 | Warnings | M017 |
| Goodsense Extra Strength Cold and Hot Medicated | MENTHOL | Geiss, Destin and Dunn, Inc. | 7585d111-775f-4fb6-a485-28cd99d88852 | 2025-10-31 | Warnings | M017 |
| Topcare Cold and Hot Medicated | MENTHOL | Topco Associates LLC | 8739aedd-165c-5ae0-e053-2a91aa0afcd0 | 2025-10-31 | Warnings | M017 |
| CVS Medicated Heat 1 ct | CAPSAICIN | CVS Pharmacy, Inc. | d41dce5b-e698-4930-8869-040b2a973f25 | 2025-10-31 | Warnings | M017 |
| Coralite Medicated Heat | CAPSAICIN | United Exchange Corp. | a0b89c7e-80bc-43c4-840c-5fd567f60b21 | 2025-10-31 | Warnings | M017 |
| Dragon with Arnical Pain Relief | MENTHOL | Genomma Lab USA Inc. | b4cbb7b6-cb71-9721-e053-2995a90a2b2c | 2025-10-31 | 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 |
|---|---|---|---|---|---|---|---|---|
| 41167-0035-0 | 41167003500 | 1 TUBE in 1 CARTON (41167-0035-0) / 28 g in 1 TUBE | 1 tube | 2007-12-01 | 0000-00-00 | No | No | Current |
| 41167-0035-1 | 41167003501 | 2 TUBE in 1 CARTON (41167-0035-1) / 56 g in 1 TUBE | 2 tube | 2023-01-01 | No | No | Current | |
| 41167-0035-2 | 41167003502 | 1 TUBE in 1 CARTON (41167-0035-2) > 35 g in 1 TUBE | 1 tube | 2007-12-01 | 0000-00-00 | No | No | Current |
| 41167-0035-3 | 41167003503 | 1 TUBE in 1 CARTON (41167-0035-3) > 56 g in 1 TUBE | 1 tube | 2007-12-01 | 0000-00-00 | No | No | Current |