Itch Relief

Product NDC: 68421-8300
11-digit product format: 684218300
Labeler code: 68421
Product ID: 68421-8300_34310875-b4c0-4ee6-aa05-3c07dbdfca4b
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Cintas First Aid & Safety
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-05-13
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 20 g/L
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68421-8300		I	Inactivated by FDA	2026-10-05
excluded product	product	68421-8300		I	Inactivated by FDA	2026-10-05
excluded package	package	68421-8300	68421-8300-1	I	Inactivated by FDA	2026-10-05
excluded package	package	68421-8300	68421-8300-0	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 76 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68421-8300-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68421-8300-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68421-8300-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68421-8300-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68421-8300-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68421-8300-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68421-8300-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68421-8300-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68421-8300-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68421-8300-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68421-8300-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68421-8300-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68421-8300-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68421-8300-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68421-8300-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68421-8300-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68421-8300-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68421-8300-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68421-8300-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68421-8300-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68421-8300-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68421-8300-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68421-8300-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68421-8300-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68421-8300-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68421-8300-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68421-8300-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68421-8300-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68421-8300-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68421-8300-0	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68421-8300-0	2021-01-29	C162847	48780-1	ba0f9c33-35c7-a910-e053-dadaa90a0b85	Xpect First Aid ITCH RELIEF SPRAY Itch Relief Spray
68421-8300-1	2021-01-29	C162847	48780-1	ba0f9c33-3fd2-a910-e053-dadaa90a0b85	Respond ITCH RELIEF SPRAY Itch Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68421-8300-1	Itch Relief	0.0591 L in 1 BOTTLE, SPRAY	LIQUID	0.0591		4
68421-8300-0	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 [CINTAS FIRST AID & SAFETY]	3
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
C12-15 PARETH-9	INACTIVE INGREDIENT	H3ZIY6WP1R	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
water	INACTIVE INGREDIENT	059QF0KO0R	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3
diphenhydramine hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
C12-15 PARETH-9	INACTIVE INGREDIENT	H3ZIY6WP1R	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
diazolidinyl urea	INACTIVE INGREDIENT	H5RIZ3MPW4	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2
water	INACTIVE INGREDIENT	059QF0KO0R	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68421-8300	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	4	Legacy NDC, 1 package rows	20191231_92ed55fa-6713-43be-be55-6ba77f052c5d.zip
68421-8300	ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]	3	Legacy NDC, 1 package rows	20191231_fdcec01b-e4fe-4440-b6e1-572a13c49661.zip

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	92ed55fa-6713-43be-be55-6ba77f052c5d	4
1050080	diphenhydramine hydrochloride 20 MG/ML Topical Spray	SCD	92ed55fa-6713-43be-be55-6ba77f052c5d	4
1050080	diphenhydramine HCl 2 % Topical Spray	SY	92ed55fa-6713-43be-be55-6ba77f052c5d	4
1050080	diphenhydrAMINE HCl 2 % Topical Spray	PSN	fdcec01b-e4fe-4440-b6e1-572a13c49661	3
1050080	diphenhydramine hydrochloride 20 MG/ML Topical Spray	SCD	fdcec01b-e4fe-4440-b6e1-572a13c49661	3
1050080	diphenhydramine HCl 2 % Topical Spray	SY	fdcec01b-e4fe-4440-b6e1-572a13c49661	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68421-8300-0	68421830000	0.0591 L in 1 BOTTLE, SPRAY	0.0591 l	Historical
68421-8300-1	68421830001	0.0591 L in 1 BOTTLE, SPRAY	0.0591 l	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Respond ITCH RELIEF SPRAY Itch Relief Spray	Cintas First Aid & Safety \| Safetec of America, Inc.	2015-09-03	HUMAN OTC DRUG LABEL	4
Xpect First Aid ITCH RELIEF SPRAY Itch Relief Spray	Cintas First Aid & Safety \| Safetec of America, Inc.	2013-05-13	HUMAN OTC DRUG LABEL	3