Pro Plus

Product NDC: 80069-009
11-digit product format: 800690009
Labeler code: 80069
Product ID: 80069-009_06349c9e-a31c-4b0b-b0bd-939de33d65eb
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine HCl, Tetracaine HCl
Dosage form: CREAM
Route: TOPICAL
Labeler: Dermal Source, Inc.
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-04-10
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE
Active strength: 50 mg/29.5735mL; mg/29.5735mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
5NF5D4OPCI	TETRACAINE HYDROCHLORIDE	136-47-0	TETRACAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80069-009-01	80069000901	25.8768 mL in 1 BOTTLE, PLASTIC (80069-009-01)	25.8768 ml	2021-04-10	0000-00-00	No	No	Current