Home NDC 11344-812 Clear Anti-Itch
Product NDC 11344-812
11-digit product format 113440812
Labeler code 11344
Product ID 11344-812_5b87a395-fb78-70b0-e063-6394a90a8839
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine HCl, Zinc acetate
Dosage form LOTION
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-29
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength 10; 1 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Clear Anti-Itch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL ZINC ACETATE 1 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-812-30 Clear Anti-Itch 177 mL in 1 BOTTLE, PLASTIC LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-812 CLEAR ANTI-ITCH (PRAMOXINE HCL, ZINC ACETATE) LOTION [CONSUMER PRODUCT PARTNERS, LLC] 1 Current NDC, 1 package rows 20240730_b5b810b8-97c0-4ed5-bd30-17dc01e08d61.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 39 of 68 · 1,357 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 11344-812-30 11344081230 177 mL in 1 BOTTLE, PLASTIC (11344-812-30) 177 ml 2024-07-29 No No Current