bite and itch

Generic: diphenhydramine hydrochloride, pramoxine hydrochloride

Labeler: weeks & leo co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bite and itch
Generic Name diphenhydramine hydrochloride, pramoxine hydrochloride
Labeler weeks & leo co., inc.
Dosage Form LOTION
Routes
CUTANEOUS
Active Ingredients

diphenhydramine hydrochloride 2 g/100mL, pramoxine hydrochloride 1 g/100mL

Manufacturer
Weeks & Leo Co., Inc.

Identifiers & Regulatory

Product NDC 11383-192
Product ID 11383-192_28650b5a-ed6f-199c-e063-6394a90a9dac
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2015-06-15

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11383192
Hyphenated Format 11383-192

Supplemental Identifiers

RxCUI
1292321
UNII
TC2D6JAD40 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bite and itch (source: ndc)
Generic Name diphenhydramine hydrochloride, pramoxine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
CUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2 g/100mL
  • 1 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLE
  • 118 mL in 1 BOTTLE (11383-192-04)
source: ndc

Packages (2)

11383-192-01 1 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLE 11383-192-04 118 mL in 1 BOTTLE (11383-192-04)

Ingredients (2)

diphenhydramine hydrochloride (2 g/100mL) pramoxine hydrochloride (1 g/100mL)

Linked Drug Pages (1)

Bite and Itch ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["CUTANEOUS"], "spl_id": "28650b5a-ed6f-199c-e063-6394a90a9dac", "openfda": {"unii": ["TC2D6JAD40", "88AYB867L5"], "rxcui": ["1292321"], "spl_set_id": ["0a4d471b-c3f3-0a6a-e063-6394a90ad57b"], "manufacturer_name": ["Weeks & Leo Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (11383-192-01)  / 118 mL in 1 BOTTLE", "package_ndc": "11383-192-01", "marketing_start_date": "20150615"}, {"sample": false, "description": "118 mL in 1 BOTTLE (11383-192-04)", "package_ndc": "11383-192-04", "marketing_start_date": "20150615"}], "brand_name": "Bite and Itch", "product_id": "11383-192_28650b5a-ed6f-199c-e063-6394a90a9dac", "dosage_form": "LOTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "11383-192", "generic_name": "Diphenhydramine Hydrochloride, Pramoxine Hydrochloride", "labeler_name": "Weeks & Leo Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bite and Itch", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "2 g/100mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 g/100mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150615", "listing_expiration_date": "20261231"}