Tetracaine
- Product NDC
- 71888-103
- 11-digit product format
- 718880103
- Labeler code
- 71888
- Product ID
- 71888-103_47faba68-aab7-7eb8-e063-6294a90a3931
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Tetracaine
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bellus Medical, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-01
- Substance
- TETRACAINE HYDROCHLORIDE
- Active strength
- 20 mg/1000mL
- Pharmacologic classes
- Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tetracaine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TETRACAINE HYDROCHLORIDE | 20 mg/1000mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5NF5D4OPCI |
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 |
|---|
| 71888-103-01 | Tetracaine | 4 mL in 1 PACKET | GEL | 4 | | 4 |
| 71888-103-02 | Tetracaine | 12 in 1 BOX | GEL | 12 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71888-103 | TETRACAINE GEL [BELLUS MEDICAL, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241120_60cabb5f-606b-7a74-e053-2a91aa0ac024.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71888-103-01 | 71888010301 | 4 mL in 1 PACKET | 4 ml | | | | Historical |
| 71888-103-02 | 71888010302 | 12 PACKET in 1 BOX (71888-103-02) / 4 mL in 1 PACKET (71888-103-01) | 12 packet | 2017-06-01 | No | No | Historical |