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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f4c801b-d894-4fa3-b024-6ca41a5f2a95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-8300-1	2024-02-13	C162847	48780-1	1030e365-2119-111a-e063-dadaa90a10e2	61010-8300, Itch Relief Spray
61010-8300-1	2024-01-30	C162847	48780-1	1030e365-2119-111a-e063-dadaa90a10e2	61010-8300, Itch Relief Spray

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
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 93 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WaxRx EarAcheRx Pain Relieving Drops	4% LIDOCAINE HCL	DOCTOR EASY MEDICAL PRODUCTS, LLC	34156655-8706-f0a4-e063-6294a90acc90	2025-05-01	Warnings	Exact identifier application number: M017
foster and thrive anti itch cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Strategic Sourcing Services LLC	bb08293d-5db8-4cc8-9fe3-bd02061dbeb9	2025-04-30	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee6e48-243e-4ded-e063-6394a90a987d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3304e362-dcda-3f5e-e063-6294a90a7015	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2f2f753d-c791-e863-e063-6394a90aec5d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3162c96a-061d-2971-e063-6394a90a9b74	2025-04-29	Warnings	Exact identifier application number: M017
Ivarest Poison Ivy Removal and Itch Relief	PRAMOXINE HYDROCHLORIDE	Blistex Inc.	dedbf5d9-0f86-4f32-8321-da86c9838c0a	2025-04-29	Warnings	Exact identifier application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-on	MENTHOL	Veridian Healthcare	33dae8a8-4197-f276-e063-6294a90aea83	2025-04-28	Warnings	Exact identifier application number: M017
HealthWise Roll-on Menthol Pain Relief Gel	MENTHOL	Veridian Healthcare	33dbb939-9397-7e70-e063-6294a90ac8f4	2025-04-28	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	fa1a98bc-c233-410d-a20e-71111c897372	2025-04-28	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Medcore LLC	b961906c-fe66-466b-af2c-072781fa098b	2025-04-28	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Knee and Elbow	LIDOCAINE	Walgreen Co.	a3fb4c78-1493-4ba4-ae83-502dd825ed67	2025-04-25	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Back	LIDOCAINE	Walgreen Co.	e6bfd342-c0db-46b9-b5e6-5acbd860adf1	2025-04-25	Warnings	Exact identifier application number: M017
Electrum Numb Foam	LIDOCAINE HCI	RENU LABORATORIES, LLC	c8472932-28b7-9189-e053-2a95a90a44df	2025-04-25	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	66a2fd60-1757-45cc-a195-ecb9241dca2a	2025-04-24	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	3385cddb-609f-62e8-e063-6294a90add81	2025-04-24	Warnings	Exact identifier application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2bd8aae0-2606-c7f2-e063-6294a90a9a20	2025-04-22	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1050080	diphenhydrAMINE HCl 2 % Topical Spray	PSN	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	3
1050080	diphenhydramine hydrochloride 20 MG/ML Topical Spray	SCD	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	3
1050080	diphenhydramine HCl 2 % Topical Spray	SY	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	3

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