Home NDC 11383-192-04 Bite and Itch
Product NDC 11383-192
Requested package NDC 11383-192-04
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 DIPHENHYDRAMINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength 2; 1 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 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 2 g/100mL DIPHENHYDRAMINE HYDROCHLORIDE 1 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 1 of 153 · 3,056 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On MENTHOL Chattem, Inc. aa40c907-eeb5-4fda-b35e-439cbecc178c 2026-07-31 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Dry LIDOCAINE Chattem, Inc. 008abaaa-5e12-4246-a7f5-66f3966acf28 2026-07-30 Warnings Exact identifier application number: M017 Icy Hot Performance No-Mess Pain Relief Cream MENTHOL 16%, CAMPHOR 11% Chattem, Inc. 5e3e272a-c001-4f57-9535-521ccc85ae65 2026-07-30 Warnings Exact identifier application number: M017 Auixudin Lidocaine Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Enokon Medical Instrument Co., Ltd. 57bc7b9e-e2f7-724b-e063-6394a90ab36f 2026-07-29 Warnings Exact identifier application number: M017 Jinfahe Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 57bcd9c5-767e-b634-e063-6394a90a2878 2026-07-29 Warnings Exact identifier application number: M017 Maximun Strength Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Meijer Distribution Inc d0468514-58ea-4d8f-b634-a65bf95c0316 2026-07-29 Warnings Exact identifier application number: M017 Oudetas Lidocaine Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 57ca9220-2778-790a-e063-6294a90af506 2026-07-29 Warnings Exact identifier application number: M017 Aspercreme Lidocaine No-Mess plus Lavender LIDOCAINE HCL Chattem, Inc. 3948a3d2-ce04-4703-8709-211e75c9c38d 2026-07-29 Warnings Exact identifier application number: M017 LidoPro LIDOCAINE AND MENTHOL Clinic Pharma cdfd6b39-b430-4e95-a0f7-682cf3d78b52 2026-07-28 Warnings Exact identifier application number: M017 LidoPro Patch (Lidocaine 4%, Menthol 1%) LIDOCAINE AND MENTHOL PATCH Clinic Pharma 2b4d2105-b7ad-2695-e063-6394a90a999b 2026-07-28 Warnings Exact identifier application number: M017 Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE DLC Laboratories, Inc. 5c3976da-a6cb-4b94-ae41-3e86b1ab13cb 2026-07-28 Warnings Exact identifier application number: M017 Muscle Rub Cream MENTHOL 10%, METHYL SALICYLATE 15% Preferred Pharmaceuticals Inc. 9e7568b6-52ae-4f7a-9bfd-503fd80a297e 2026-07-28 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Rosemary and Mint LIDOCAINE HYDROCHLORIDE Chattem, Inc. 9d40bfea-85d0-4943-83e9-0c16e79a011c 2026-07-28 Warnings Exact identifier application number: M017 KENS PAIN AND ARTHRITIS FORMULA MENTHOL Eezaway Relief Inc 35834473-3ad5-41ec-a110-e742aa7e2ee4 2026-07-28 Warnings Exact identifier application number: M017 DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 57935b64-6e2e-85d0-e063-6394a90a7428 2026-07-27 Warnings Exact identifier application number: M017 1% Hydrocortisone Anti-itch 1% HYDROCORTISONE ANTI-ITCH ALAINA HEALTHCARE PRIVATE LIMITED b8416467-55f7-4e5f-a5cb-3abd3e2bb577 2026-07-27 Warnings Exact identifier application number: M017 OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH MENTHOL OWELL NATURAL 8 LLC 57984bc2-bf1d-c423-e063-6394a90a06ae 2026-07-27 Warnings Exact identifier application number: M017 Original Pain Relief TOPICAL ANALGESIC LOTION Real Time Pain Relief Inc 579bd303-9a50-4d66-e063-6294a90a6141 2026-07-27 Warnings Exact identifier application number: M017 Lidfix Pain Relief Patch Lidocaine LIDOCAINE HETERO HEALTHCARE LIMITED 2149f0e3-1983-4f02-929e-ecd20357f4bb 2026-07-27 Warnings Exact identifier application number: M017 RectoProtect LIDOCAINE Akron Pharma Inc. 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb 2026-07-27 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11383-192-04 11383019204 118 mL in 1 BOTTLE (11383-192-04) 118 ml 2015-06-15 No No Current