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 |
|---|---|---|---|---|---|---|
| CVS Health Pain Relieving | CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE | Natural Essentials, Inc. | f7198485-3d68-41d2-b9b9-f932a0649310 | 2024-12-04 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | 364924d3-fac3-4f4e-9b40-decd4ec48245 | 2024-12-03 | Warnings | M017 |
| Bite and Itch | DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE | Weeks & Leo Co., Inc. | 0a4d471b-c3f3-0a6a-e063-6394a90ad57b | 2024-12-03 | Warnings | M017 |
| Menthol | AMISH ORIGINS MEDICATED | Amish Origins LLC | 547abe39-3af3-4d70-99dd-caf8d67feda2 | 2024-12-03 | Warnings | M017 |
| Meijer Small Cold-Hot Medicated Patches | MENTHOL | Meijer Distribution Inc | be6012d6-2062-45ba-8fc4-abf14cff5845 | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | acdd5622-a9a7-4cc3-877e-57efea23303f | 2024-12-03 | Warnings | M017 |
| Salonpas | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu Pharmaceutical Co., Inc. | 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5 | 2024-12-03 | Warnings | M017 |
| Salonpas DEEP Relieving | CAMPHOR, MENTHOL, METHYL SALICYLATE | Hisamitsu America, Inc. | a4ddb2b9-d023-4c8c-9285-93d51f93207d | 2024-12-03 | Warnings | M017 |
| Salonpas LIDOCAINE PLUS | BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE | Hisamitsu America, Inc. | ea5b4a7f-d47d-4dbd-9288-c01329e387e5 | 2024-12-03 | Warnings | M017 |
| Hempvana Ultra Strength Pain Relief - Overnight | LIDOCAINE | Telebrands Corp | 1030d478-6805-6579-e063-6294a90a0c76 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Cold Sore Treatment | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 106c0bb2-f2e2-4255-867d-d09ff6a5a2e6 | 2024-12-02 | Warnings | M017 |
| Campho-Phenique Antiseptic | CAMPHOR (SYNTHETIC) AND PHENOL | Foundation Consumer Healthcare LLC | 82edaef0-0709-4ae1-a664-c9c5adb91ee1 | 2024-12-02 | Warnings | M017 |
| Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On | THERMACARE CAPSAICIN ROLL ON | Clarion Brands LLC | 2850f7e7-41dd-f5f9-e063-6394a90ae519 | 2024-12-02 | Warnings | M017 |
| BURN | LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE | NINGBO TIANBO FIRST AID PRODUCT CO., LTD. | 2ec1cf79-c341-4b79-9047-ce29f0dff419 | 2024-11-29 | Warnings | M017 |
| TheraCare Pain Relieving Lidocaine Cream | LIDOCAINE HYDROCHLORIDE | Veridian Healthcare | 242204d3-efc7-f7a9-e063-6294a90a5af1 | 2024-11-27 | Warnings | M017 |
| Walgreens Flexible Pain Relieving Lidocaine | LIDOCAINE, MENTHOL | Walgreen Co. | 6f070fa3-a61a-4523-a470-ab58bf9400a3 | 2024-11-27 | Warnings | M017 |
| Benadryl Original Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Kenvue Brands LLC | 920c50cb-9bdd-4a36-bb3d-c2559db73327 | 2024-11-26 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 884907a8-c884-4cce-ac10-9d4848fdba3e | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 7f067e95-e01c-4b9a-a02e-0af097beb18c | 2024-11-22 | Warnings | M017 |
| Universal ARTHRITIS and SPORT | METHYL SALICYLATE, CAPSICUM | Universal Distribution Center LLC | 9ece9b3a-0092-4c1c-a913-c2fefcd70541 | 2024-11-22 | 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 |