Home NDC 80684-142 Thera Plus Maximum Strength Feminine Anti-Itch
Product NDC 80684-142
11-digit product format 806840142
Labeler code 80684
Product ID 80684-142_2f0c45da-c4f2-bd12-e063-6394a90aba99
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE, RESORCINOL
Dosage form CREAM
Route TOPICAL
Labeler FOURSTAR GROUP USA, INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-26
Substance BENZOCAINE; RESORCINOL
Active strength 200; 30 mg/g; mg/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Thera Plus Maximum Strength Feminine Anti-Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/g RESORCINOL 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup YUL4LO94HK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 637518 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80684-142-00 Thera Plus Maximum Strength Feminine Anti-Itch 28 g in 1 TUBE CREAM 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-142 THERA PLUS MAXIMUM STRENGTH FEMININE ANTI-ITCH (BENZOCAINE, RESORCINOL) CREAM [FOURSTAR GROUP USA, INC.] 2 Current NDC, 1 package rows 20250228_0007e3ea-882b-4000-8e70-2bcec2c08613.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 109 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80684-142-00 80684014200 28 g in 1 TUBE (80684-142-00) 28 g 2025-02-26 No No Current