Benadryl Extra Strength Itch Relief

Product NDC: 69968-0459
11-digit product format: 699680459
Labeler code: 69968
Product ID: 69968-0459_399004db-8df3-c030-e063-6294a90a260b
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE and Zinc Acetate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Kenvue Brands LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-06-01
Substance: ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 1; 20 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Benadryl Extra Strength Itch Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC ACETATE	1 mg/mL
DIPHENHYDRAMINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FM5526K07A	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1294589	Internal RxNorm lookup
1294591	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
309d9be0-e367-429a-a1fa-ab7855477c8a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0459-1	Benadryl Extra Strength Itch Relief	1 in 1 CARTON	SOLUTION	1		8
69968-0459-1	Benadryl Extra Strength Itch Relief	14 mL in 1 APPLICATOR	SOLUTION	14		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69968-0459-1	ML - Milliliter	69968-0459	9fdb0baa-a35e-4a36-8cfc-37a065d225af	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0459	BENADRYL EXTRA STRENGTH ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SOLUTION [KENVUE BRANDS LLC]	7	Current NDC, Legacy NDC, 2 package rows	20241103_309d9be0-e367-429a-a1fa-ab7855477c8a.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 129 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier application number: M017
Ultra Balm	MENTHOL AND METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	de997baf-aa04-474e-b912-3fc67e720d0b	2024-07-19	Warnings	Exact identifier application number: M017
Ling Nam Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	3f16cce3-366f-41f3-8829-6de4082a8c19	2024-07-19	Warnings	Exact identifier application number: M017
Koong Yick Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	bc33e185-3b42-98b5-e053-2995a90a6308	2024-07-18	Warnings	Exact identifier application number: M017
Koong Yick Hung Fa	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	9c8a121d-6da2-4435-a2d7-a0b71d10740d	2024-07-18	Warnings	Exact identifier application number: M017
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON	PAIN RELIEF HEAT THERAPY ROLL-ON	Shenzhen Sam Technology Co., Ltd.	1d0b7b8f-9e5d-00f7-e063-6394a90af87c	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.	PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0b94ec-f956-dff2-e063-6294a90aca4a	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.	PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0bf4f9-6b02-6cec-e063-6294a90a36c7	2024-07-12	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE HCI 2.0%	Trifecta Pharmaceuticals USA, LLC.	e5e524cd-bb22-715f-e053-2995a90ab5d3	2024-07-12	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	1d10e3ca-dc93-8e1a-e063-6394a90a47c0	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.	PAIN RELIEF HEAT THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d199826-1b27-b6e7-e063-6394a90a69ad	2024-07-12	Warnings	Exact identifier application number: M017
Tidl Pain Relief Morning Therapy Spray.	PAIN RELIEF MORNING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d19d070-3818-73de-e063-6394a90a8958	2024-07-12	Warnings	Exact identifier application number: M017
Hydrocortisone with aloe	HYDROCORTISONE WITH ALOE ANTI ITCH	NeilMed Pharmaceuticals Inc.	032b9f58-5f64-04dd-e063-6294a90a6bb9	2024-07-10	Warnings	Exact identifier application number: M017
Octagon Pain Relief	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	9926f733-1506-4224-9d70-b1813cd81ec3	2024-07-08	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1294591	Benadryl 2 % / 0.1 % Topical Solution	PSN	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294589	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Solution	PSN	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294591	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Solution [Benadryl Itch Stopping]	SBD	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294589	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Solution	SCD	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294591	Benadryl Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Solution	SY	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294591	Benadryl Extra Strength Itch Relief Stick (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Solution	SY	309d9be0-e367-429a-a1fa-ab7855477c8a	8
1294589	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Solution	SY	309d9be0-e367-429a-a1fa-ab7855477c8a	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0459-1	69968045901	1 APPLICATOR in 1 CARTON (69968-0459-1) / 14 mL in 1 APPLICATOR	1 applicator	2019-06-01	0000-00-00	No	No	Current