Home NDC 82645-901 Itch Relief Gel
Product NDC 82645-901
11-digit product format 826450901
Labeler code 82645
Product ID 82645-901_0d1cd578-e127-6e8e-e063-6294a90a5060
Type HUMAN OTC DRUG
Nonproprietary name Itch Relief Gel
Dosage form GEL
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-20
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 2 mg/100mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Itch Relief Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 2 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII 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 82645-901-94 Itch Relief Gel 118 mL in 1 CONTAINER GEL 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82645-901 ITCH RELIEF GEL GEL [PHARMA NOBIS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231223_e42f484d-a641-3489-e053-2a95a90a4254.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 125 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DermacinRx Penetral Cream CAPSAICIN PureTek Corporation 1e343a52-6071-3230-e054-00144ff8d46c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 36abfc2c-d424-4df8-968d-866342c96a56 2024-10-02 Warnings Exact identifier application number: M017 Eagle Balm CAMPHOR MENTHOL Eagle Indo Pharma, PT 87614869-9675-2c76-e053-2a95a90a48a9 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited d9a93daa-4e24-6690-e053-2a95a90a147c 2024-10-02 Warnings Exact identifier application number: M017 Eagle Extra Strength MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 5e02fbe3-5bc7-430e-b661-3a760ddd8fe0 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Borden Company (Private) Limited c62a4313-2c07-5f58-e053-2995a90a083a 2024-10-02 Warnings Exact identifier application number: M017 Eagle Medicated Aromatic CAMPHOR MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT e272ec90-3cd9-5b70-e053-2a95a90a1df4 2024-10-02 Warnings Exact identifier application number: M017 RUGBY HYDROCORTISONE WITH ALOE HYDROCORTISONE A-S Medication Solutions b2674075-aaa4-4c77-bcaa-a76336b3c321 2024-10-02 Warnings Exact identifier application number: M017 Herb Street Anti-Itch Stick HYDROCORTISONE Balassa Laboratories Inc. 8717faae-59c3-4c6f-9ef1-285c0d2445ed 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Backache and Sore Muscle Relief MENTHOL Balassa Laboratories Inc. aeac1b64-8689-4b3d-a41c-db41061257b5 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Arthritis Relief MENTHOL/CAMPHOR Balassa Laboratories Inc. a9d8ceb7-def0-415f-8fc1-ff8dd3e41855 2024-10-01 Warnings Exact identifier application number: M017 Lido King Lidocaine 4% Pain Relieving Gel-Patch LIDOCAINE Galaxy Bio, Inc. 2243734a-4ea2-a5e5-e063-6294a90aba15 2024-10-01 Warnings Exact identifier application number: M017 Medicated Herbal Lip Balm MENTHOL Earth Mama Angel Baby LLC 1cc2391e-6a7a-609c-e063-6394a90a6305 2024-10-01 Warnings Exact identifier application number: M017 CVS Health Lidocaine Plus Pain Relieving LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL NATURAL ESSENTIALS, INC. 1adb9b74-4a01-4461-b845-f3aedcb3f810 2024-10-01 Warnings Exact identifier application number: M017 Circata CAPSAICIN PureTek Corporation b67161d7-cc5c-e971-e053-2995a90acbe7 2024-10-01 Warnings Exact identifier application number: M017 Menticam CAMPHOR,MENTHOL, METHYL SALICYLATE PureTek Corporation ffea2e97-777f-434b-e053-6394a90a3a63 2024-10-01 Warnings Exact identifier application number: M017 Herb Street Sore Muscle Relief METHYL SALICYLATE Balassa Laboratories Inc. e43943c2-d4cd-44c5-a0ff-403a8d42860f 2024-10-01 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Kroger Company 68dab606-0385-48b7-9a7b-a2cf83d20393 2024-09-29 Warnings Exact identifier application number: M017 kirkland signature hydrocortisone plus maximum strength HYDROCORTISONE Costco Wholesale Company 481341c5-db1f-43fb-aed7-f40495a4eab8 2024-09-29 Warnings Exact identifier application number: M017 Care One hydrocortisone maximum strength HYDROCORTISONE American Sales Company 32593229-d0ac-4d6c-831a-089fc6e76152 2024-09-29 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82645-901-94 82645090194 118 mL in 1 CONTAINER (82645-901-94) 118 ml 2018-12-20 0000-00-00 No No Current