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 92 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	Warnings	Exact identifier application number: M017
SORE NO MORE COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	9aa1f0ac-3baf-4e45-9e3a-c28a99b22909	2025-05-12	Warnings	Exact identifier application number: M017
Calm and Correct Serum with Lidocaine	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2025-05-09	Warnings	Exact identifier application number: M017
Mqupin Knee Patch	KNEE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	09772e4b-8193-3771-e063-6394a90a9516	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Exact identifier application number: M017
GNP Extra Strength Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Amerisource Bergen	34a66224-ef3c-e36e-e063-6394a90ac99d	2025-05-08	Warnings	Exact identifier application number: M017
Good Neighbor Muscle Rub Cream	CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,	Amerisource Bergen	34924bb9-e3e8-70e6-e063-6294a90aaa8c	2025-05-07	Warnings	Exact identifier application number: M017
DermaRad Relief Post Radiation Calming	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	e5d64929-fb9c-7ebc-e053-2995a90a9318	2025-05-07	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee0235-5a6e-0ea1-e063-6394a90a89a5	2025-05-06	Warnings	Exact identifier application number: M017
DermaRad Relief	LIDOCAINE EMULSION	RENU LABORATORIES, LLC	d5e11f73-918b-eeac-e053-2995a90a4a83	2025-05-06	Warnings	Exact identifier application number: M017
Plantar Fasciitis Pain Relief Gel-Patch	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	34838622-b092-afeb-e063-6294a90ae7db	2025-05-06	Warnings	Exact identifier application number: M017
Climax Shield Delay	BENZOCAINE	PRODUCT MAX GROUP INC	9c720cdc-f753-47ce-95ff-3b26e461a0ab	2025-05-05	Warnings	Exact identifier application number: M017
PediFix Lidocaine Pain-Relief Patches	LIDOCAINE PAIN-RELIEF PATCHES	PediFix, Inc	346550b9-d2ba-184e-e063-6394a90a591a	2025-05-05	Warnings	Exact identifier application number: M017
Walgreens Stop Itch Gel	DIPHENHYDRAMINE HCL	Walgreens Co	23586336-8f46-3dcd-e063-6394a90accc9	2025-05-04	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