GOLD LABEL
- Product NDC
- 82617-104
- 11-digit product format
- 826170104
- Labeler code
- 82617
- Product ID
- 82617-104_47f81e54-0ce3-439d-e063-6294a90a2abe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- SCALP TECH INC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-23
- Substance
- EPINEPHRINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
- Active strength
- .01; 5 g/100mL; g/100mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GOLD LABEL
- Brand name suffix
- B NUMB
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE HYDROCHLORIDE | .01 g/100mL |
| EPINEPHRINE HYDROCHLORIDE | 5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V13007Z41A, WBB047OO38 |
| Rxcui | 2601579 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82617-104-59 | GOLD LABELB NUMB | 59 mL in 1 BOTTLE, SPRAY | SPRAY | 59 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82617-104 | GOLD LABEL B NUMB (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE) SPRAY [SCALP TECH INC] | 1 | Current NDC, 1 package rows | 20240224_1211590a-13b5-2e75-e063-6394a90a0f86.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82617-104-59 | 82617010459 | 59 mL in 1 BOTTLE, SPRAY (82617-104-59) | 59 ml | 2024-02-22 | No | No | Current |