Home NDC 69968-0459 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.
DailyMed Product Concepts# 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 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 133 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. 1dc21c95-b419-4175-85f8-040b73060d37 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Roll-On Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. d94ae654-ce25-4bff-b9bd-24a0e0e8568a 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. f8bff018-fb4f-47b4-b8f8-4a496aede346 2024-03-20 Warnings Exact identifier application number: M017 Rugby Arthritis Pain Relieving Topical Analgesic CAPSAICIN Rugby Laboratories 8f1bc075-97ac-4154-8768-0d878104c3ba 2024-03-14 Warnings Exact identifier application number: M017 Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM Rugby Laboratories 2b65cb6a-4364-4770-b7b9-5c4637edd01a 2024-03-14 Warnings Exact identifier application number: M017 Leader Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER fd06d17f-4dff-42a9-a84f-904809ceb981 2024-03-13 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR EROS GLOBAL b3495c95-ba4b-9459-e053-2a95a90a710f 2024-03-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 1369e70f-7a61-7078-e063-6394a90a9a88 2024-03-11 Warnings Exact identifier application number: M017 Pain Reliever Cream MENTHOL 10%, METHYL SALICYLATE 15% Trifecta Pharmaceuticals USA, LLC. 130665d6-3de8-cb91-e063-6294a90a2083 2024-03-06 Warnings Exact identifier application number: M017 Dermachange Aid Anti-Itch DIPHENHYDRAMINE HCL Private Label Beauty and Wellness 12ed906c-d028-0ff7-e063-6394a90aaa52 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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