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 81 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017 LILAS PERIOD MENTHOL Lilas Wellness, Inc. 5ea53b4b-45e6-48a7-8090-09c3a21e7f63 2025-08-11 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Roll-On LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 31639407-0f11-bde2-e063-6294a90af694 2025-08-10 Warnings Exact identifier application number: M017 Chinese Red Tiger Lidocaine Patches LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 20cd369c-3e98-3d8f-e063-6394a90a0824 2025-08-10 Warnings Exact identifier application number: M017 Treatonic LIDOCAINE PAIN RELIEF LIDOCAINE 4% 100 KARMA INC 3bd66b03-ac82-2d45-e063-6294a90a610a 2025-08-08 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Advanced Rx of Tennessee, LLC 3bdcef94-d06f-9152-e063-6294a90a6072 2025-08-08 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Advanced Rx of Tennessee, LLC 3bdd0c52-29d8-ab67-e063-6294a90a9c45 2025-08-08 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Advanced Rx of Tennessee, LLC 3bdd3015-349a-0fac-e063-6394a90afe41 2025-08-08 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Advanced Rx of Tennessee, LLC 3bdd6b3d-7180-288c-e063-6394a90a1785 2025-08-08 Warnings Exact identifier application number: M017 Good Sense Pain Relief Roll On LIDOCAINE HCL Geiss, Destin & Dunn, Inc 38e76fd6-e5fb-493c-e063-6294a90afed4 2025-08-08 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