coretex anti-itch gel (65753-400)

Drug Facts

Product Profile

Brand Name coretex anti-itch gel

Generic Name camphor, diphenhydramine, zinc acetate

Labeler coretex products inc

Dosage Form GEL

Routes

TOPICAL

Active Ingredients

camphor (synthetic) .1 g/100mL, diphenhydramine hydrochloride 2 g/100mL, zinc acetate 1 g/100mL

Manufacturer

CoreTex Products Inc

Identifiers & Regulatory

Product NDC 65753-400

Product ID 65753-400_23d94b44-5be0-f9fc-e063-6294a90a1e74

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M017

Listing Expiration 2026-12-31

Marketing Start 2019-11-25

Pharmacologic Class

Classes

copper absorption inhibitor [epc] decreased copper ion absorption [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65753400

Hyphenated Format 65753-400

Supplemental Identifiers

RxCUI

2263170

UPC

0698229266637 0698229266668

UNII

5TJD82A1ET TC2D6JAD40 FM5526K07A

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 coretex anti-itch gel (source: ndc)

Generic Name camphor, diphenhydramine, zinc acetate (source: ndc)

Application Number M017 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

.1 g/100mL
2 g/100mL
1 g/100mL

source: ndc

Packaging

59 mL in 1 BOTTLE (65753-400-02)
177 mL in 1 BOTTLE (65753-400-04)
25 POUCH in 1 CONTAINER (65753-400-13) / 1 mL in 1 POUCH
300 POUCH in 1 CONTAINER (65753-400-14) / 1 mL in 1 POUCH

source: ndc

Packages (4)

65753-400-02 59 mL in 1 BOTTLE (65753-400-02) 65753-400-04 177 mL in 1 BOTTLE (65753-400-04) 65753-400-13 25 POUCH in 1 CONTAINER (65753-400-13) / 1 mL in 1 POUCH 65753-400-14 300 POUCH in 1 CONTAINER (65753-400-14) / 1 mL in 1 POUCH

Ingredients (3)

camphor (synthetic) (.1 g/100mL) diphenhydramine hydrochloride (2 g/100mL) zinc acetate (1 g/100mL)

Linked Drug Pages (1)

CoreTex Anti-Itch Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "23d94b44-5be0-f9fc-e063-6294a90a1e74", "openfda": {"upc": ["0698229266637", "0698229266668"], "unii": ["5TJD82A1ET", "TC2D6JAD40", "FM5526K07A"], "rxcui": ["2263170"], "spl_set_id": ["9849da49-d867-fae5-e053-2a95a90a399c"], "manufacturer_name": ["CoreTex Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 BOTTLE (65753-400-02)", "package_ndc": "65753-400-02", "marketing_start_date": "20191126"}, {"sample": false, "description": "177 mL in 1 BOTTLE (65753-400-04)", "package_ndc": "65753-400-04", "marketing_start_date": "20191126"}, {"sample": false, "description": "25 POUCH in 1 CONTAINER (65753-400-13)  / 1 mL in 1 POUCH", "package_ndc": "65753-400-13", "marketing_start_date": "20191126"}, {"sample": false, "description": "300 POUCH in 1 CONTAINER (65753-400-14)  / 1 mL in 1 POUCH", "package_ndc": "65753-400-14", "marketing_start_date": "20191126"}], "brand_name": "CoreTex Anti-Itch Gel", "product_id": "65753-400_23d94b44-5be0-f9fc-e063-6294a90a1e74", "dosage_form": "GEL", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "65753-400", "generic_name": "camphor, diphenhydramine, zinc acetate", "labeler_name": "CoreTex Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CoreTex Anti-Itch Gel", "active_ingredients": [{"name": "CAMPHOR (SYNTHETIC)", "strength": ".1 g/100mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "2 g/100mL"}, {"name": "ZINC ACETATE", "strength": "1 g/100mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191125", "listing_expiration_date": "20261231"}