Hydrocortisone Topical Solution
- Brand(s)
- Cortizone-10, Locoid, Scalpicin Itch Relief, Selsun Blue Scalp Itch, Texacort
- Category(s)
- otc, prescription
- SPL Type(s)
- Human OTC, Human Prescription
- Master SPL
- Chattem, Inc. (2015-05-22)
- Oldest Current Product
- 1992-12-15
- License(s)
- NDA, ANDA, OTC MONOGRAPH FINAL, OTC MONOGRAPH NOT FINAL
- RxNORM
- TOPICAL SOLUTION\HYDROCORTISONE
- FDAOB
- TOPICAL\SOLUTION\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE BUTYRATE - SPL Active
- TOPICAL\LIQUID\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE BUTYRATE - SPL Moiety
- TOPICAL\LIQUID\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE
product(s) by strength(s)
hydrocortisone 10 mg/ml topical solution
product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 115095400 | Scalpicin Itch Relief | OTC MONOGRAPH FINAL | Combe Incorporated | 1992-12-15 | HYDROCORTISONE | TOPICAL | LIQUID | 45d51ae3-404a-44c6-8cbd-3eb30fbad1e7 |
| 2 | 411670032 | Cortizone-10 | OTC MONOGRAPH NOT FINAL | Chattem, Inc. | 2008-10-01 | HYDROCORTISONE | TOPICAL | LIQUID | beb73818-cd88-44ff-8ecd-b02b910b53b7 |
| 3 | 411676040 | Selsun Blue Scalp Itch | OTC MONOGRAPH NOT FINAL | Chattem, Inc. | 2013-10-01 | HYDROCORTISONE | TOPICAL | LIQUID | da86eff4-bf3e-4836-861e-ffe01dd5ff62 |
| 4 | 597790318 | OTC MONOGRAPH FINAL | Cvs | 2010-07-16 | HYDROCORTISONE | TOPICAL | LIQUID | 0d72f26d-304c-4541-844a-76865f7c7fc5 | |
| 5 | 617340415 | OTC MONOGRAPH NOT FINAL | Delon Laboratories (1990) Ltd | 2014-09-08 | HYDROCORTISONE | TOPICAL | SOLUTION | 8aa175be-cc8b-4ff6-9746-c95efbe0d032 | |
| 6 | 638240850 | Scalpicin Itch Relief | OTC MONOGRAPH NOT FINAL | Reckitt Benckiser Llc | 2012-01-16 | HYDROCORTISONE | TOPICAL | LIQUID | 94a3625d-8022-4bd4-a8a1-6ae380be6677 |
| 7 | 638240851 | Scalpicin Itch Relief | OTC MONOGRAPH NOT FINAL | Reckitt Benckiser Llc | 2012-10-15 | HYDROCORTISONE | TOPICAL | LIQUID | 7b1a29fa-b266-43e6-a87b-aa3c96ab4041 |
hydrocortisone 25 mg/ml topical solution
generic product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 001780455 | Texacort | ANDA | Mission Pharmacal Company | 2011-12-15 | HYDROCORTISONE | TOPICAL | SOLUTION | ANDA081271 | 25279d46-6bad-471f-8bd6-736d53cfd942 |
hydrocortisone 5 mg/ml topical solution
product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | spl |
|---|---|---|---|---|---|---|---|---|
| 1 | 252800004 | OTC MONOGRAPH NOT FINAL | Loesch Laboratory Consultants, Inc. | 2014-06-26 | HYDROCORTISONE | TOPICAL | LIQUID | 595bf774-2d0f-4316-a328-071c87aae2fe |
hydrocortisone butyrate 1 mg/ml topical solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 434780273 | NDA | Rouses Point Pharm | 2010-02-24 | HYDROCORTISONE BUTYRATE | TOPICAL | SOLUTION | NDA019116 | 7db9b9c4-9591-4ac4-abff-9c3c203cecb1 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 516724061 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 2004-01-14 | HYDROCORTISONE BUTYRATE | TOPICAL | SOLUTION | ANDA076364 | 51176835-598d-4da7-8a00-6bd36f52aa82 |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA076364 | HYDROCORTISONE BUTYRATE | TARO PHARMACEUTICAL INDUSTRIES LTD | 2004-01-14 | ANDA076364_001 | |
| 2 | ANDA080425 | TEXACORT | True | MISSION PHARMACAL CO | ANDA080425_001 | |
| 3 | ANDA081271 | TEXACORT | MISSION PHARMACAL CO | 1992-04-17 | ANDA081271_001 | |
| 4 | ANDA088214 | PENECORT | True | ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC | 1984-06-06 | ANDA088214_001 |
| 5 | NDA019116 | LOCOID | PRECISION DERMATOLOGY INC | 1987-02-25 | NDA019116_001 | |
| 6 | NDA019819 | LOCOID | True | YAMANOUCHI EUROPE BV | 1988-09-15 | NDA019819_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076364_001 | RX | HYDROCORTISONE BUTYRATE (0.1%) | TOPICAL | SOLUTION | False | AT | 2004-01-14 | HYDROCORTISONE BUTYRATE |
| 2 | ANDA080425_001 | discontinued | HYDROCORTISONE (1%) | TOPICAL | SOLUTION | False | TEXACORT | ||
| 3 | ANDA081271_001 | RX | HYDROCORTISONE (2.5%) | TOPICAL | SOLUTION | True | 1992-04-17 | TEXACORT | |
| 4 | ANDA088214_001 | discontinued | HYDROCORTISONE (1%) | TOPICAL | SOLUTION | False | 1984-06-06 | PENECORT | |
| 5 | NDA019116_001 | RX | HYDROCORTISONE BUTYRATE (0.1%) | TOPICAL | SOLUTION | True | AT | 1987-02-25 | LOCOID |
| 6 | NDA019819_001 | discontinued | HYDROCORTISONE BUTYRATE (0.1%) | TOPICAL | SOLUTION | False | 1988-09-15 | LOCOID |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 0d72f26d-304c-4541-844a-76865f7c7fc5 (view SPL) | drug facts | otc | Human OTC | Cvs | manufacture | 2010-07-16 | 1 | 597790318 | |
| 2 | 25279d46-6bad-471f-8bd6-736d53cfd942 (view SPL) | Texacort Topical Solution 2.5% | prescription | Human Prescription | Mission Pharmacal Company | MANUFACTURE | 2012-03-12 | 1 | 001780455 | |
| 3 | 45d51ae3-404a-44c6-8cbd-3eb30fbad1e7 (view SPL) | Scalpicin Scalp Itch Medication Maximum Strength | otc | Human OTC | Combe Incorporated | MANUFACTURE | 2009-12-31 | 2 | 115095400 | |
| 4 | 51176835-598d-4da7-8a00-6bd36f52aa82 (view SPL) | Hydrocortisone Butyrate Ointment, 0.1% Hydrocortisone Butyrate Cream USP, 0.1% Hydrocortisone Butyrate Topical Solution, 0.1% | prescription | Human Prescription | Taro Pharmaceuticals U.S.A., Inc. | MANUFACTURE | 2015-01-22 | 3 | 516724061, 516724074, 516724083 | Hydrocortisone Topical Ointment Hydrocortisone Topical Cream |
| 5 | 595bf774-2d0f-4316-a328-071c87aae2fe (view SPL) | Loesch Anti-Itch Therapy | otc | Human OTC | Loesch Laboratory Consultants, Inc. | manufacture | 2014-06-26 | 1 | 252800004 | |
| 6 | 7b1a29fa-b266-43e6-a87b-aa3c96ab4041 (view SPL) | Scalpicin Anti-Itch Maximum Strength | otc | Human OTC | Reckitt Benckiser Llc | 2012-11-16 | 1 | 638240851 | ||
| 7 | 7db9b9c4-9591-4ac4-abff-9c3c203cecb1 (view SPL) | Hydrocortisone Butyrate Solution, 0.1% For Dermatological Use Only | prescription | Human Prescription | Rouses Point Pharm | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2014-07-09 | 4 | 434780273 | |
| 8 | 8aa175be-cc8b-4ff6-9746-c95efbe0d032 (view SPL) | Drug Facts | otc | Human OTC | Delon Laboratories (1990) Ltd | label, manufacture, pack | 2014-09-08 | 1 | 617340415 | |
| 9 | 94a3625d-8022-4bd4-a8a1-6ae380be6677 (view SPL) | Scalpicin Maximum Strength | otc | Human OTC | Reckitt Benckiser Llc | 2012-06-26 | 1 | 638240850 | ||
| 10 | beb73818-cd88-44ff-8ecd-b02b910b53b7 (view SPL) | Cortizone 10 Easy Relief | otc | Human OTC | Chattem, Inc. | ANALYSIS, MANUFACTURE, RECOVERY, RELABEL, REPACK | 2009-11-06 | 2 | 411670032 | |
| 11 | c3360b20-8409-4a8a-b77a-4f6fb1ac6b25 (view SPL) | Locoid (hydrocortisone butyrate) Solution, 0.1% | prescription | Human Prescription | Onset Dermatologics, Llc | MANUFACTURE | 2014-11-05 | 3 | 167810391 | |
| 12 | da86eff4-bf3e-4836-861e-ffe01dd5ff62 (view SPL) | Selsun Blue Scalp Itch Treatment | otc | Human OTC | Chattem, Inc. | 2015-05-22 | 2 | 411676040 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII