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 99 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tylenol Precise Nighttime Pain Relieving	CAMPHOR, MENTHOL	Kenvue Brands LLC	2ef4fe16-0820-6aad-e063-6294a90a8449	2025-02-25	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Preferred Pharmaceuticals Inc.	c259ef92-5d07-4590-adf1-3a106333eee0	2025-02-21	Warnings	Exact identifier application number: M017
Cortizone 10 Ultra Soothing Itch Relief	HYDROCORTISONE	Chattem, Inc.	8a9e2d32-a65f-4253-8041-4146f4e3b738	2025-02-21	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll On	MENTHOL	ADP Health Limited	420d8cdc-f47f-4d33-bf25-9033ff266c49	2025-02-19	Warnings	Exact identifier application number: M017
AVCOO Pain Relief	MENTHOL	ADP Health Limited	700ce2cf-749e-40be-91c3-850d9b2168ca	2025-02-19	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	Jell Pharmaceuticals Pvt. Ltd	2e7c49de-5438-4858-e063-6294a90ad98c	2025-02-19	Warnings	Exact identifier application number: M017
VTROUY Tattoo Numbing Cream	TATTOO NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2e899851-b3cd-0758-e063-6294a90afea8	2025-02-19	Warnings	Exact identifier application number: M017
Pomada Dragon Pain Relief	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE	Genomma Lab USA	9d98f48b-6d88-4df9-9459-7cf7ba5de044	2025-02-19	Warnings	Exact identifier application number: M017
Pain Relieving Cream	HISTAMINE DIHYDROCHLORIDE	Mediapower, Inc. DBA Dr Newton's And Naturals	9eeea033-ae87-4d83-85d0-b8fa653a0806	2025-02-19	Warnings	Exact identifier application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular	ALUMINUM CHLOROHYDRATE	Sodalis USA, LLC	7839cf53-dbd2-4dbb-a309-1581d51f8adc	2025-02-18	Warnings	Exact identifier application number: M017
CANNA NUMB Roll On	LIDOCAINE HYDROCHLORIDE, MENTHOL	Cannanumb LLC	c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4	2025-02-17	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz.	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	7173b141-123e-6cd4-e053-2a95a90a8600	2025-02-12	Warnings	Exact identifier application number: M017
Vaporizing Chest Rub 4 oz. 3 pk	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rejoice International Inc.	71c186a1-8283-2482-e053-2995a90acc1f	2025-02-12	Warnings	Exact identifier application number: M017
Roman Swipes	BENZOCAINE	Roman Health Ventures Inc.	7f0eac8c-7235-99d8-e053-2a91aa0a634e	2025-02-12	Warnings	Exact identifier application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR	EVI LABS	EVI LABS	2df7658d-83d3-41ac-e063-6294a90ab1dd	2025-02-12	Warnings	Exact identifier application number: M017
Signature Care Medicated Pain Relief Patch	LIDOCAINE	Safeway, Inc.	2165a342-5f8b-78e0-e063-6394a90a06c4	2025-02-12	Warnings	Exact identifier application number: M017
CheeZheng Pain Relieveing Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd.	abcebdf1-9037-4094-93e1-ce8f20b18ea7	2025-02-11	Warnings	Exact identifier application number: M017
Tibetree Pain Relieveing Medicated Plaster	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	4216bd48-5c62-4e87-adcc-67bf7152d64d	2025-02-11	Warnings	Exact identifier application number: M017
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Olakino Therapeutics LLC	2a41a621-c6f7-5819-e063-6394a90ae67d	2025-02-07	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