Home NDC 11383-192 Bite and Itch
Product NDC 11383-192
11-digit product format 113830192
Labeler code 11383
Product ID 11383-192_28650b5a-ed6f-199c-e063-6394a90a9dac
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride, Pramoxine Hydrochloride
Dosage form LOTION
Route CUTANEOUS
Labeler Weeks & Leo Co., Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-15
Substance PRAMOXINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 1; 2 g/100mL; g/100mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 Bite and Itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 1 g/100mL DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1292321 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 11383-192-01 Bite and Itch 118 mL in 1 BOTTLE LOTION 118 3 11383-192-01 Bite and Itch 1 in 1 CARTON LOTION 1 3 11383-192-04 Bite and Itch 118 mL in 1 BOTTLE LOTION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11383-192 BITE AND ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) LOTION [WEEKS & LEO CO., INC.] 3 Current NDC, 3 package rows 20241206_0a4d471b-c3f3-0a6a-e063-6394a90ad57b.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 18 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 11383-192-01 11383019201 1 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLE 1 bottle 2015-06-15 No No Current 11383-192-04 11383019204 118 mL in 1 BOTTLE (11383-192-04) 118 ml 2015-06-15 No No Current