NDC 71888-103

Tetracaine

Tetracaine

Tetracaine is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Bellus Medical, Llc. The primary component is Tetracaine Hydrochloride.

Product ID71888-103_60cabb5f-606c-7a74-e053-2a91aa0ac024
NDC71888-103
Product TypeHuman Otc Drug
Proprietary NameTetracaine
Generic NameTetracaine
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2017-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameBellus Medical, LLC
Substance NameTETRACAINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1000mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71888-103-02

12 PACKET in 1 BOX (71888-103-02) > 4 mL in 1 PACKET (71888-103-01)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71888-103-02 [71888010302]

Tetracaine GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-01
Inactivation Date2020-01-31

NDC 71888-103-01 [71888010301]

Tetracaine GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-01

Drug Details

Active Ingredients

IngredientStrength
TETRACAINE HYDROCHLORIDE20 mg/1000mL

OpenFDA Data

SPL SET ID:60cabb5f-606b-7a74-e053-2a91aa0ac024
Manufacturer
UNII

NDC Crossover Matching brand name "Tetracaine" or generic name "Tetracaine"

NDCBrand NameGeneric Name
17478-045TetracaineTetracaine HCl
42494-437TetracaineTETRACAINE HYDROCHLORIDE
63629-9160TetracaineTETRACAINE HYDROCHLORIDE
71888-103TetracaineTetracaine
70372-729BLT 3TETRACAINE
37945-212Burn Creamtetracaine
54723-004FranklyNumb 3Tetracaine
67194-020Numfast Tetracaine GreenTETRACAINE
67194-013Tetragel Punch Topical AnalgesicTETRACAINE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.