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 |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 20 mg/g |
| ZINC ACETATE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
| FM5526K07A | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a1c1b878-d58f-41ff-b7a8-477f28c52667 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HEEL PAIN Relief Gel Roll-On | MENTHOL | Guangzhou Zhupuyou E-commerce Co., Ltd | 36bacb5f-c1af-2e97-e063-6394a90afe5c | 2025-06-04 | Warnings | M017 |
| Capsaicin 0.075% Cream | CAPSAICIN | ViolaCare, Inc. | 30911225-a6d7-4b2b-9005-b733373e2877 | 2025-06-04 | Warnings | M017 |
| LidoGuard | LIDOCAINE HCL | ViolaCare, Inc. | 531383aa-4f0f-4fe0-91f4-d809b39f160f | 2025-06-04 | Warnings | M017 |
| HealthWise Lidocaine and Menthol | LIDOCAINE AND MENTHOL | Veridian Healthcare | 36c27642-f913-1aad-e063-6294a90a4343 | 2025-06-04 | Warnings | M017 |
| HealthWise Ultra OTC Strength Pain Relief Cream | CAMPHOR, MENTHOL, AND METHYL SALICYLATE | Veridian Healthcare | 36c3bbf9-a559-4c0d-e063-6394a90a8a1a | 2025-06-04 | Warnings | M017 |
| Everlight Survival Sting Relief Pad | BENZOCAINE | Yiwu Ori-Power Medtech Co.,Ltd. | 364c9882-339e-fe22-e063-6294a90a37f4 | 2025-06-04 | Warnings | M017 |
| LIGHTS Sting Relief Prep Pad | BENZOCAINE | Lights Medical Manufacture Co., Ltd. | 4f4d7758-be62-4304-8871-087a90497fa5 | 2025-06-04 | Warnings | M017 |
| Elsophie Nicotine Patches Quit | NICOTINE PATCHES QUIT SMOKING | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 36b63da9-94cc-b52a-e063-6394a90a5029 | 2025-06-03 | Warnings | M017 |
| Burn | LIDOCAINE HYDROCHLORIDE | J&A Digital Inc. | d4b09055-b93e-466f-9e24-cae098af6e24 | 2025-06-02 | Warnings | M017 |
| RE-LEVE | MENTHOL | SOMBRA COSMETICS INC. | b4b39d79-0439-41e7-adca-e5ccb8f44e40 | 2025-05-29 | Warnings | M017 |
| PAIN NO MORE THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | f7bacc8e-6a8b-4cd8-bd0e-68890bee5818 | 2025-05-29 | Warnings | M017 |
| DermaD ANTI-ITCH Therapeutic | SALICYLIC ACID | Chen Cohen Industries Inc. | 8f4a57cb-0a5b-42b0-a325-1f92f3942ad9 | 2025-05-29 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Sun Pharmaceutical Industries, Inc. | f7aecfb4-c194-4554-8d05-4e46005e654b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | b679ed7b-9d88-4eff-9743-567affe0fe2b | 2025-05-27 | Warnings | M017 |
| RockSauce Warming Massage Roll On | MENTHOL, METHYL SALICYLATE | Nantong Health & Beyond Hygienic Products Inc. | 28eb8273-5789-4f33-bbbe-3a5ec7bc7929 | 2025-05-27 | Warnings | M017 |
| AUVON Pain Relief Cream | LIDOCAINE | SHENZHEN YUWEN E-COMMERCE CO., LTD. | 358c2632-3b90-1c54-e063-6294a90ad461 | 2025-05-22 | Warnings | M017 |
| WelAhead by Welmate Lidocaine 5% Roll-on | LIDOCAINE 5% | OTC PHARM LLC | 0b75e83e-8c7b-6247-e063-6294a90ac413 | 2025-05-21 | Warnings | M017 |
| Bliss Republic | LIDOCAINE NUMBING EXTRA STRENGTH CREAM | Sargass Group Limited Liability Company | 35aba13a-95e6-a395-e063-6294a90a5bdc | 2025-05-21 | Warnings | M017 |
| Xpect Stopain Clinical | MENTHOL | Cintas Corporation | e911478f-7153-4700-b945-92ec54972f45 | 2025-05-21 | Warnings | M017 |
| LidoPro Patch (Lidocaine 4%, Menthol 1%) | LIDOCAINE AND MENTHOL PATCH | Preferred Pharmaceuticals Inc. | 0976a898-8d79-4b85-b473-c8ad32b4fd00 | 2025-05-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| 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 | 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 |