GoodSense
- Product NDC
- 50804-080
- 11-digit product format
- 508040080
- Labeler code
- 50804
- Product ID
- 50804-080_d93e1136-2e52-4245-9842-897480bba17e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Geiss, Destin & Dunn, Inc.
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50804-080-01 | GoodSenseTerbinafine Hydrochloride | 15 g in 1 TUBE | CREAM | 15 | | 2 |
| 50804-080-01 | GoodSenseTerbinafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50804-080 | GOODSENSE TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) CREAM [GEISS, DESTIN & DUNN, INC.] | 2 | Legacy NDC, 2 package rows | 20150424_2a5b2b88-7066-43d8-8b72-9d4d85c36bc1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 50804-080-01 | 50804008001 | 15 g in 1 TUBE | 15 g | Historical |