FDA.reportPublic FDA data

Benadryl Extra Strength Itch Cooling

Product NDC
69968-0270
11-digit product format
699680270
Labeler code
69968
Product ID
69968-0270_3a30b0bf-ee88-12ff-e063-6294a90a0a4b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 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 Cooling
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/mL
ZINC ACETATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053138Internal RxNorm lookup
1294592Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7eae5dc-9db6-4bdf-9179-76060e75e044Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0270-2Benadryl Extra Strength Itch Cooling59 mL in 1 BOTTLE, SPRAYSPRAY597

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0270-2ML - Milliliter69968-02702da2e2d8-d770-497b-bf69-a2d0e8d4e81512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0270BENADRYL EXTRA STRENGTH ITCH COOLING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) SPRAY [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 1 package rows20241108_a7eae5dc-9db6-4bdf-9179-76060e75e044.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 103 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294592Benadryl ITCH COOLING 2 % / 0.1 % Topical SprayPSNa7eae5dc-9db6-4bdf-9179-76060e75e0447
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSNa7eae5dc-9db6-4bdf-9179-76060e75e0447
1294592diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Spray [Benadryl Itch Stopping]SBDa7eae5dc-9db6-4bdf-9179-76060e75e0447
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCDa7eae5dc-9db6-4bdf-9179-76060e75e0447
1294592Benadryl Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySYa7eae5dc-9db6-4bdf-9179-76060e75e0447
1294592Benadryl Extra Strength Itch Relief (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySYa7eae5dc-9db6-4bdf-9179-76060e75e0447
1294592Benadryl Itch Cooling (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySYa7eae5dc-9db6-4bdf-9179-76060e75e0447
1294592Benadryl ReadyMist Itch Stopping (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical SpraySYa7eae5dc-9db6-4bdf-9179-76060e75e0447
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySYa7eae5dc-9db6-4bdf-9179-76060e75e0447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0270-26996802700259 mL in 1 BOTTLE, SPRAY (69968-0270-2) 59 ml2019-04-010000-00-00NoNoCurrent