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 141 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Regular Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	CVS	87473ace-d834-e43f-e053-2a95a90a819c	2023-12-11	Warnings	Exact identifier application number: M017
Katinko External Analgesic Oil	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	5881fc35-3293-4f0b-801a-afcd6feb9496	2023-12-08	Warnings	Exact identifier application number: M017
Katinko Pain And Itch Relieving	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Greenstone Pharmaceutical Inc.	fe907fa4-4a01-4974-b71f-9cd980b4eaa2	2023-12-08	Warnings, Adverse reactions	Exact identifier application number: M017
Cycle	MENTHOL	La Mend, Inc.	cfc0bcde-ef91-1e6c-e053-2a95a90ab79e	2023-12-07	Warnings	Exact identifier application number: M017
Hemorrhoidal Pain Relief Cream	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	WALGREENS	03bbe146-f185-bcfa-e063-6394a90a85bf	2023-12-04	Warnings	Exact identifier application number: M017
Quatriderm Anti-itch	HYDROCORTISONE	OPMX LLC	83e59e10-9878-e5c2-e053-2a91aa0af25e	2023-12-04	Warnings	Exact identifier application number: M017
TACT	DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL	Sato Pharmaceutical Inc., Ltd.	b6e2ee24-69de-4dfd-9081-b9537b7a7bad	2023-12-04	Warnings	Exact identifier application number: M017
Overnight Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	2cbd0966-4cf9-4271-bd53-6672b1ed2a99	2023-12-04	Warnings	Exact identifier application number: M017
Prolayed Lidocaine Male Genital Desensitizer	LIDOCAINE	ViaDerma Distribution, Inc.	9c5ad0d0-ca7a-4321-9334-f06f3f6be18f	2023-12-02	Warnings	Exact identifier application number: M017
Liberdol Topical Analgesic	METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)	ViaDerma Distribution, Inc	ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8	2023-12-01	Warnings	Exact identifier application number: M017
Prolayed	LIDOCAINE	MATRIX MIXOLOGY, INC	ae317876-adb1-6d13-e053-2995a90a74af	2023-12-01	Warnings	Exact identifier application number: M017
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	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