Zensa Numbing Gel
- Product NDC
- 69805-400
- 11-digit product format
- 698050400
- Labeler code
- 69805
- Product ID
- 69805-400_065a6eec-3897-0da8-e063-6394a90a849d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lidocaine 5%, Phenylephrine Hydrochloride 0.25%
- Dosage form
- GEL
- Route
- RECTAL
- Labeler
- Alera Skin Care Products Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-25
- Substance
- LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 5; .25 g/100g; g/100g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zensa Numbing Gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIDOCAINE | 5 g/100g |
| PHENYLEPHRINE HYDROCHLORIDE | .25 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98PI200987, 04JA59TNSJ |
| Rxcui | 2621576 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69805-400-01 | Zensa Numbing Gel | 30 g in 1 TUBE | GEL | 30 | | 1 |
| 69805-400-01 | Zensa Numbing Gel | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69805-400 | ZENSA NUMBING GEL (LIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%) GEL [ALERA SKIN CARE PRODUCTS INC.] | 1 | Current NDC, 2 package rows | 20231016_065a6eec-3896-0da8-e063-6394a90a849d.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 |
|---|
| 69805-400-01 | 69805040001 | 1 TUBE in 1 CARTON (69805-400-01) / 30 g in 1 TUBE | 1 tube | 2023-09-25 | No | No | Historical |