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 |
|---|---|---|---|---|---|---|
| Bactine Max Bandage | LIDOCAINE | WellSpring Pharmaceutical Corporation | 465dc46e-6435-4569-9516-f648d0fe0f09 | 2023-12-21 | Warnings | M017 |
| Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC | CAMPHOR, MENTHOL, METHYL SALICYLATE | LABORATORIOS QUANTIUM LLC | c4efa317-8dd1-49e1-b7ca-9df2147edd3e | 2023-12-21 | Warnings | M017 |
| DDM Camphor Spirit | CAMPHOR 10% | Discount Drug Mart | 5d56cbe6-4e48-79eb-e053-2a91aa0a74d3 | 2023-12-20 | Warnings | M017 |
| Quality Choice Camphor Spirit | CAMPHOR 10% | Chain Drug Market Association | 8d352a67-2024-43d0-b525-038d398949e6 | 2023-12-20 | Warnings | M017 |
| Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Chain Drug Market Association | 2cd60df3-bfde-4747-ba4f-7121612f2e63 | 2023-12-20 | Warnings | M017 |
| Poison Ivy Wash | PRAMOXINE HCL | Chain Drug Market Association | 873a546b-90ae-50cb-e053-2a91aa0adbfb | 2023-12-20 | Warnings | M017 |
| Premier Value Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Pharmacy Value Alliance LLC | 9d63f8ed-fc50-0d84-e053-2a95a90a6e92 | 2023-12-20 | Warnings | M017 |
| Ear Drops | CARBAMIDE PEROXIDE 6.5% | CVS Pharmacy | 8a872991-01af-5fd0-e053-2995a90ac7f4 | 2023-12-20 | Warnings | M017 |
| CVS Cold and Hot Roll-On | COOL AND HEAT PAIN RELIEF | CVS Pharmacy | b8cc578a-be6d-90c0-e053-2995a90a7742 | 2023-12-20 | Warnings | M017 |
| Sunmark Camphor Spirit | CAMPHOR 10% | Strategic Sourcing Services LLC | 667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa | 2023-12-19 | Warnings | M017 |
| DDM Instant Antiseptic Pain Relief | CAMPHOR 10.8% AND PHENOL 4.7% | Discount Drug Mart | 5d56c74f-604d-4fed-e053-2a91aa0a417c | 2023-12-19 | Warnings | M017 |
| HEB Camphor Phenol | CAMPHOR 10.8% AND PHENOL 4.7% | H E B | 5d573883-001d-e5a4-e053-2991aa0a6203 | 2023-12-18 | Warnings | M017 |
| Petrocort Antipruritic Lip 21 | HYDROCORTISONE | Clinical Formula LLC | 7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b | 2023-12-15 | Warnings | M017 |
| DermaWound Wound Care Venous Stasis | BENZOCAINE HYDROCHLORIDE | Progressive Doctors, LLC | 6221ba86-8b7f-48c8-8284-6950f9fc36b1 | 2023-12-15 | Warnings | M017 |
| Lidocaine Pain Relief Roll-On | LIDOCAINE 4% | Humco Holding Group, Inc. | a8be9e46-1616-40a9-e053-2a95a90ac3bc | 2023-12-15 | Warnings | M017 |
| Hot/Cold Menthol 16% Roll-On | HOT/COLD MENTHOL 16% ROLL-ON | Humco Holding Group, Inc | a8bf9744-9979-13c1-e053-2a95a90a30aa | 2023-12-15 | Warnings | M017 |
| Freds Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | Discount Drug Mart | 8697b932-da5a-717e-e053-2a91aa0afcae | 2023-12-12 | Warnings | M017 |
| CVS Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | CVS | 86972218-31fe-6942-e053-2991aa0a8850 | 2023-12-12 | Warnings | M017 |
| Best Choice Medicated anti itch | PRAMOXINE HYDROCHLORIDE, MENTHOL | value merchandisers | 869631f8-aa1e-8ea4-e053-2a91aa0a5c57 | 2023-12-12 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE 1% | Weeks & Leo Co., Inc. | 0c5325e3-4796-856c-e063-6394a90a1f90 | 2023-12-12 | 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 |