FDA.reportPublic FDA data

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

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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g
ZINC ACETATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, FM5526K07A
Rxcui1087026, 1111764

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0223-1Benadryl Extra StrengthItch Stopping1 in 1 CARTONCREAM110
69968-0223-1Benadryl Extra StrengthItch Stopping28.3 g in 1 TUBECREAM28.310
69968-0223-2Benadryl Extra StrengthItch Stopping28.3 g in 1 TUBECREAM28.310
69968-0223-1Johnson and Johnson All Purpose First Aid Kit28.3 g in 1 TUBECREAM28.3 g20 mg in 1g7
69968-0223-1Johnson and Johnson All Purpose First Aid Kit1 in 1 CARTONCREAM1 mg in 1g7
69968-0223-1Johnson and Johnson First Aid All Purpose160 CT1 in 1 CARTONCREAM20 mg in 1g3
69968-0223-1Johnson and Johnson First Aid All Purpose160 CT28.3 g in 1 TUBECREAM28.3 g1 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0223BENADRYL EXTRA STRENGTH ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 3 package rows20241116_a1c1b878-d58f-41ff-b7a8-477f28c52667.zip
69968-0223JOHNSON AND JOHNSON ALL PURPOSE FIRST AID KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241116_5cdb47c5-7951-4279-8a05-0a3199d3dd45.zip
69968-0223JOHNSON 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]2Current NDC, Legacy NDC20241116_f3933330-2550-4a88-e053-2a95a90a3997.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSNa1c1b878-d58f-41ff-b7a8-477f28c5266710
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNa1c1b878-d58f-41ff-b7a8-477f28c5266710
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBDa1c1b878-d58f-41ff-b7a8-477f28c5266710
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDa1c1b878-d58f-41ff-b7a8-477f28c5266710
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSYa1c1b878-d58f-41ff-b7a8-477f28c5266710
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYa1c1b878-d58f-41ff-b7a8-477f28c5266710
198440acetaminophen 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440APAP 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459APAP 500 MG Oral Tablet [Tylenol]SY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf3933330-2550-4a88-e053-2a95a90a39973
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBDf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletSCDf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
198440APAP 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
209459APAP 500 MG Oral Tablet [Tylenol]SYf3933330-2550-4a88-e053-2a95a90a39973
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0223-1699680223011 TUBE in 1 CARTON (69968-0223-1) / 28.3 g in 1 TUBE1 tube2009-11-010000-00-00NoNoCurrent
69968-0223-26996802230228.3 g in 1 TUBE (69968-0223-2) 28.3 g2009-11-01NoNoCurrent