Benadryl Extra Strength

Product NDC: 69968-0223
11-digit product format: 699680223
Labeler code: 69968
Product ID: 69968-0223_26b4b1f0-5cb0-7132-e063-6394a90a2c2f
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Kenvue Brands LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-11-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 20; 1 mg/g; mg/g
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
Brand name suffix: Itch Stopping
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087026	Internal RxNorm lookup
1111764	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
a1c1b878-d58f-41ff-b7a8-477f28c52667	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
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0223-1	Benadryl Extra StrengthItch Stopping	1 in 1 CARTON	CREAM	1		10
69968-0223-1	Benadryl Extra StrengthItch Stopping	28.3 g in 1 TUBE	CREAM	28.3		10
69968-0223-2	Benadryl Extra StrengthItch Stopping	28.3 g in 1 TUBE	CREAM	28.3		10
69968-0223-1	Johnson and Johnson All Purpose First Aid Kit	28.3 g in 1 TUBE	CREAM	28.3 g	20 mg in 1g	7
69968-0223-1	Johnson and Johnson All Purpose First Aid Kit	1 in 1 CARTON	CREAM		1 mg in 1g	7
69968-0223-1	Johnson and Johnson First Aid All Purpose160 CT	1 in 1 CARTON	CREAM		20 mg in 1g	3
69968-0223-1	Johnson and Johnson First Aid All Purpose160 CT	28.3 g in 1 TUBE	CREAM	28.3 g	1 mg in 1g	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69968-0223-1	GM - Gram	69968-0223	6bb12e4b-56e2-4424-9641-c234236d08c9	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0223	BENADRYL EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 3 package rows	20241116_a1c1b878-d58f-41ff-b7a8-477f28c52667.zip
69968-0223	JOHNSON AND JOHNSON ALL PURPOSE FIRST AID KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]	6	Current NDC, Legacy NDC	20241116_5cdb47c5-7951-4279-8a05-0a3199d3dd45.zip
69968-0223	JOHNSON AND JOHNSON FIRST AID ALL PURPOSE 160 CT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]	2	Current NDC, Legacy NDC	20241116_f3933330-2550-4a88-e053-2a95a90a3997.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 137 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	Warnings	Exact identifier application number: M017
Cool n Heat	COOL N HEAT	NeilMed Pharmaceuticals, Inc.	a24cde17-280b-8358-e053-2a95a90af67d	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Anti-Itch	ANTI-ITCH SPRAY	NeilMed Pharmaceuticals Inc.	b3d34d9e-85d9-df4e-e053-2a95a90ac8d9	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Hot and Cold Pain Relief	PAIN RELIEF SPRAY	NeilMed Pharmaceuticals Inc.	b3d02111-7499-c2d4-e053-2a95a90ae1de	2024-01-11	Warnings	Exact identifier application number: M017
Cooling Itch Relief	COOLING ITCH RELIEF	NeilMed Pharmaceuticals, Inc	a24bdea0-18e8-8a5e-e053-2995a90acea2	2024-01-11	Warnings	Exact identifier application number: M017
Lightning X Burn	LIDOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0e69a971-0c6e-6ebe-e063-6394a90a0b33	2024-01-08	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Exact identifier application number: M017
2nd CHANCE MOBILITY Pain Relief	HISTAMINE DIHYDROCHLORIDE	ALPHA NUTRITION, LLC	575097ac-9fc9-4391-99d1-dff9b34817e3	2024-01-08	Warnings	Exact identifier application number: M017
Tiger Balm Arthritis Rub	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	80932288-4797-40d3-aa8a-6af686fb67ad	2024-01-08	Warnings	Exact identifier application number: M017
OPRAVA	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	05552560-e283-5eba-e063-6294a90a65f7	2024-01-06	Warnings	Exact identifier application number: M017
MED O-3 BIO-	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	02707552-03d9-3ad2-e063-6294a90a3472	2024-01-06	Warnings	Exact identifier application number: M017
Sumifun Knee Relieving Patch	KNEE RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e7e73ec-ab33-9235-e063-6394a90ad950	2024-01-06	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE	YYBA Corp	de6dc194-c6ef-4cb5-be3f-e772ace9abaf	2024-01-03	Warnings	Exact identifier application number: M017
Equate Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Walmart Inc.	0cdc9323-f5c3-468c-a7ae-83dfd2d76626	2024-01-03	Warnings	Exact identifier application number: M017
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	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
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111764	Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical Cream	PSN	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
1111764	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]	SBD	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
1111764	Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Cream	SY	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	a1c1b878-d58f-41ff-b7a8-477f28c52667	10
198440	acetaminophen 500 MG Oral Tablet	PSN	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1111764	Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical Cream	PSN	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	PSN	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1111764	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]	SBD	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
198440	acetaminophen 500 MG Oral Tablet	SCD	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
198440	APAP 500 MG Oral Tablet	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1111764	Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Cream	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1359360	neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
209459	Tylenol 500 MG Oral Tablet	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	5cdb47c5-7951-4279-8a05-0a3199d3dd45	7
198440	acetaminophen 500 MG Oral Tablet	PSN	f3933330-2550-4a88-e053-2a95a90a3997	3
1111764	Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical Cream	PSN	f3933330-2550-4a88-e053-2a95a90a3997	3
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	f3933330-2550-4a88-e053-2a95a90a3997	3
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	PSN	f3933330-2550-4a88-e053-2a95a90a3997	3
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	f3933330-2550-4a88-e053-2a95a90a3997	3
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	f3933330-2550-4a88-e053-2a95a90a3997	3
1111764	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]	SBD	f3933330-2550-4a88-e053-2a95a90a3997	3
198440	acetaminophen 500 MG Oral Tablet	SCD	f3933330-2550-4a88-e053-2a95a90a3997	3
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	f3933330-2550-4a88-e053-2a95a90a3997	3
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	f3933330-2550-4a88-e053-2a95a90a3997	3
198440	APAP 500 MG Oral Tablet	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
1111764	Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Cream	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
1359360	neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
209459	Tylenol 500 MG Oral Tablet	SY	f3933330-2550-4a88-e053-2a95a90a3997	3
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	f3933330-2550-4a88-e053-2a95a90a3997	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0223-1	69968022301	1 TUBE in 1 CARTON (69968-0223-1) / 28.3 g in 1 TUBE	1 tube	2009-11-01	0000-00-00	No	No	Current
69968-0223-2	69968022302	28.3 g in 1 TUBE (69968-0223-2)	28.3 g	2009-11-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Johnson and Johnson All Purpose First Aid Kit	Kenvue Brands LLC	2025-11-06	HUMAN OTC DRUG LABEL	7
Johnson and Johnson First Aid Kit All Purpose 160 CT	Kenvue Brands LLC	2025-11-06	HUMAN OTC DRUG LABEL	3
Benadryl ® EXTRA STRENGTH ITCH STOPPING CREAM	Kenvue Brands LLC	2024-11-12	HUMAN OTC DRUG LABEL	10