Psoriasin Gel
- Product NDC
- 52389-166
- 11-digit product format
- 523890166
- Labeler code
- 52389
- Product ID
- 52389-166_ebf1fc75-1cd9-92fa-e053-2995a90a98ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Coal Tar Topical Gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Alva-Amco Pharmacal Companies, Inc.
- Application
- M032
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 1996-02-18
- Marketing end
- 0000-00-00
- Substance
- COAL TAR
- Active strength
- 13 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Psoriasin Gel
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COAL TAR | 12.5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R533ESO2EC |
| Rxcui | 415978, 1043397 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Coal tar | ACTIVE INGREDIENT | R533ESO2EC | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Coal tar | ACTIVE MOIETY | R533ESO2EC | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Aloe vera leaf | INACTIVE INGREDIENT | ZY81Z83H0X | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52389-166 | PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] | 13 | Legacy NDC | 20241106_a046878f-ffc7-417e-9145-5ccc176b4683.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52389-166-01 | 52389016601 | 1 TUBE in 1 CARTON (52389-166-01) > 28.35 g in 1 TUBE (52389-166-28) | 1 tube | 2013-03-15 | 0000-00-00 | No | No | Current |
| 52389-166-43 | 52389016643 | 2 TUBE in 1 BOX (52389-166-43) > 21.25 g in 1 TUBE | 2 tube | 2020-06-01 | 0000-00-00 | No | No | Current |
| 52389-166-56 | 52389016656 | 2 TUBE in 1 CARTON (52389-166-56) > 28.35 g in 1 TUBE (52389-166-28) | 2 tube | 2013-10-01 | 0000-00-00 | No | No | Current |
| 52389-166-57 | 52389016657 | 1 TUBE, WITH APPLICATOR in 1 CARTON (52389-166-57) / 56.7 g in 1 TUBE, WITH APPLICATOR | | 2024-08-05 | 2026-07-31 | 0 | | Historical |