Home NDC 61010-8300 Itch Relief
Product NDC 61010-8300
11-digit product format 610108300
Labeler code 61010
Product ID 61010-8300_109674e0-ef83-5844-e063-6394a90ae6b8
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form LIQUID
Route TOPICAL
Labeler Safetec of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-05-02
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 20.3 g/L
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1050080 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-8300-1 Itch Relief 0.0591 L in 1 BOTTLE, SPRAY LIQUID 0.0591 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 diphenhydramine ACTIVE MOIETY 8GTS82S83M ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 C12-15 PARETH-9 INACTIVE INGREDIENT H3ZIY6WP1R ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 diazolidinyl urea INACTIVE INGREDIENT H5RIZ3MPW4 ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-8300 ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240214_4f4c801b-d894-4fa3-b024-6ca41a5f2a95.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 110 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Cool and Heat MENTHOL, METHYL SALICYLATE Wal-Mart Stores Inc c5ab2426-eeca-4ba4-9f00-7790d2176471 2024-12-17 Warnings Exact identifier application number: M017 CVS Health Muscle Rub Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a 2024-12-17 Warnings Exact identifier application number: M017 DG Health Maximum Strength Pain Relieving Cleansing BENZALKONIUM CL, LIDOCAINE HCL Dollar General Corporation 64f69315-77a3-49dc-940d-efd7a29c6645 2024-12-17 Warnings Exact identifier application number: M017 Chiggerex BENZOCAINE RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH 5e5d84ab-f57f-448d-a4c1-ced38890eec2 2024-12-17 Warnings Exact identifier application number: M017 DerMend Moisturizing Anti-Itch PRAMOXINE HYDROCHLORIDE Ferndale Laboratories, Inc. 14c7fb1c-a310-4b12-ab2e-7f1c0801995c 2024-12-17 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Geri-Care Pharmaceuticals, Corp fd67566a-1076-019d-e053-6394a90a415c 2024-12-17 Warnings Exact identifier application number: M017 Extra Strength MENTHOL AND METHYL SALICYLATE NATURES FORMULAE HEALTH PRODUCTS LTD. d919b50a-5de2-1830-e053-2a95a90ab88d 2024-12-17 Warnings Exact identifier application number: M017 Cold and Heat Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Walgreen Company 1f262473-3f3c-4f3f-b507-590d06ff69a9 2024-12-17 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Walgreen Company db8cf218-7544-4871-b1c3-a50a3d3e59f1 2024-12-17 Warnings Exact identifier application number: M017 Albertsons Pain Relief Patch LIDOCAINE Safeway dc2823bb-8586-daca-e053-2995a90a2af0 2024-12-17 Warnings Exact identifier application number: M017 CAPSAICIN HEAT PATCHES BACK AND LARGE AREAS CAPSAICIN Walgreen Company e77167ab-6cb8-4d5b-838c-b0acc05e3889 2024-12-17 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Walgreen Company d9fc133d-ebaa-48f1-a6f9-62453970012b 2024-12-17 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 204b96bc-af4e-4842-8b57-7b416feb4dd9 2024-12-17 Warnings Exact identifier application number: M017 Lidocaine Dry LIDOCAINE CVS bb7955fe-5113-1662-e053-2a95a90a85a1 2024-12-16 Warnings Exact identifier application number: M017 HealthWise Medicated Original Body Powder 10 oz MENTHOL Veridian Healthcare 296b623a-14cd-0bca-e063-6394a90ac5ff 2024-12-16 Warnings Exact identifier application number: M017 HealthWise Medicated Extra Body Powder 10 oz MENTHOL Veridian Healthcare 296c9a9c-e3db-59fe-e063-6294a90a0b62 2024-12-16 Warnings Exact identifier application number: M017 Rite Aid Hot and Cold Roll On MENTHOL 16% Rite Aid fc4b2635-280b-267f-e053-6294a90a5e22 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving BENZOCAINE 20%, MENTHOL 0.5% Rite Aid e2c09e85-be0a-4e6d-e053-2995a90ad756 2024-12-15 Warnings Exact identifier application number: M017 Rugby Lidocaine LIDOCAINE 4% Rugby Laboratories d94292f7-10fc-48bf-e053-2995a90a8472 2024-12-15 Warnings Exact identifier application number: M017 Rite Aid Cortisone HYDROCORTISONE 1% Rite Aid e27353b9-23b6-3801-e053-2a95a90a6045 2024-12-15 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61010-8300-1 61010830001 .0591 L in 1 BOTTLE, SPRAY (61010-8300-1) 2013-05-02 0000-00-00 No No Current