Benadryl
- Product NDC
- 50580-226
- 11-digit product format
- 505800226
- Labeler code
- 50580
- Product ID
- 50580-226_57a6b529-75db-f06e-e063-6294a90a7dd3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-09-01
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 702f9786-7ce9-43e4-921d-e1db09612127 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-226-12 | Benadryl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 31 | |
| 50580-226-12 | Benadryl | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 31 | |
| 50580-226-20 | Benadryl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 31 | |
| 50580-226-20 | Benadryl | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 31 | |
| 50580-226-33 | Benadryl | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 31 | |
| 50580-226-33 | Benadryl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 31 | |
| 50580-226-50 | Benadryl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 31 | |
| 50580-226-50 | Benadryl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 31 | |
| 50580-226-51 | Benadryl | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 31 | |
| 50580-226-51 | Benadryl | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 31 | |
| 50580-226-52 | Benadryl | 4 in 1 CARTON | TABLET, FILM COATED | 4 | 31 | |
| 50580-226-52 | Benadryl | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 31 | |
| 50580-226-53 | Benadryl | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 31 | |
| 50580-226-54 | Benadryl | 60 in 1 CARTON | TABLET, FILM COATED | 60 | 31 | |
| 50580-226-54 | Benadryl | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 31 | |
| 50580-226-56 | Benadryl | 3 in 1 PACKAGE | TABLET, FILM COATED | 3 | 31 | |
| 50580-226-56 | Benadryl | 4 in 1 CARTON | TABLET, FILM COATED | 4 | 31 | |
| 50580-226-62 | Benadryl | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 31 | |
| 50580-226-62 | Benadryl | 4 in 1 CARTON | TABLET, FILM COATED | 4 | 31 | |
| 50580-226-70 | Benadryl | 48 in 1 BOTTLE | TABLET, FILM COATED | 48 | 31 | |
| 50580-226-70 | Benadryl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-226-10 | EA - Each | 50580-226 | 0e538188-3b26-4cf7-a5d2-7653a4c5807f | 1 | 2012-07-24 |
| 50580-226-48 | EA - Each | 50580-226 | 30dcc89c-a992-45e8-84cd-964543091fb3 | 1 | 2012-07-24 |
| 50580-226-50 | EA - Each | 50580-226 | 0c74e638-fdc6-4e03-aa02-8f64c6b47a2c | 1 | 2017-12-14 |
| 50580-226-51 | EA - Each | 50580-226 | 4b1c6774-52e1-41f4-bb46-9e3415756200 | 1 | 2013-04-01 |
| 50580-226-52 | EA - Each | 50580-226 | 05a4b0af-3905-4b1c-88a4-3fb4f226675b | 1 | 2015-10-02 |
| 50580-226-54 | EA - Each | 50580-226 | e04fc601-d017-4bc6-94ae-ecd6715d9b2f | 1 | 2022-02-07 |
| 50580-226-62 | EA - Each | 50580-226 | f56d0e68-9dd8-4cf9-b5cd-ac5e7c49552b | 1 | 2019-08-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Winco Foods Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | WinCo Foods, LLC | f54eb60d-c602-1272-e053-2995a90aa95a | 2025-12-28 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | ad4d74a8-a762-4378-9016-f7c83421073e | 2025-12-26 | Warnings | M012 |
| Sorbutuss NR | SORBUTUSS | Dextrum Laboratories Inc. | 304f1d5a-218c-51ae-e054-00144ff88e88 | 2025-12-26 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a28aa-00e9-8b9d-e063-6394a90ace2a | 2025-12-26 | Warnings | M012 |
| Creamy Strawberry Flavor Cough Drop | CREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749b83a-ea4f-d8ca-e063-6394a90a69b7 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f4a026-c4d2-2645-e063-6294a90aac58 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a13b5-6fcb-70ed-e063-6394a90a7fb3 | 2025-12-26 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a4802-7c02-ccce-e063-6394a90ad71d | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749f353-9286-15b9-e063-6394a90a7693 | 2025-12-26 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a93c2c-a663-e3d1-e063-6394a90ad859 | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine | ACETAMINOPHEN | AptaPharma Inc. | 344440bc-d810-4296-93ec-e6ae6673856b | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine Cherry | ACETAMINOPHEN | AptaPharma Inc. | 87c2b823-ed88-44f3-8f6a-df30430b40f3 | 2025-12-26 | Warnings | M012 |
| TUSSIN CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | AptaPharma Inc. | c005c6cf-7891-463e-b65d-1129ad4bf6ec | 2025-12-26 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | AptaPharma Inc. | b2cef61f-ab54-4a20-a7f7-6d3da4754e8b | 2025-12-26 | Warnings | M012 |
| CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | AptaPharma Inc. | 9ae6fe74-80cd-482a-b3b9-3acafd6708ec | 2025-12-26 | Warnings | M012 |
| Tussin Expectorant | GUAIFENESIN | AptaPharma, Inc. | ca8fa216-09c1-42b2-a95b-fa3d0f13363c | 2025-12-26 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | a9875dc9-6a27-413c-a2c7-68a86483ffc1 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f | 2025-12-26 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 702f9786-7ce9-43e4-921d-e1db09612127 | 31 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 76433e3c-142c-4704-8b2b-d602f008c377 | 4 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 17633c87-ff0f-4fde-ab23-bc43bdc3fa8e | 4 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 3 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | b1c849e5-8003-4fd3-811d-6a927523e353 | 2 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 37573ee4-4df8-4909-bbaf-9a7dbe336e8e | 2 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
| 1049632 | Benadryl 25 MG Oral Tablet | PSN | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049632 | diphenhydramine hydrochloride 25 MG Oral Tablet [Benadryl] | SBD | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049632 | Benadryl 25 MG Oral Tablet | SY | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | d3f44425-db82-4569-8ed0-2fe990b23384 | 1 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 1 |
| 1049632 | Benadryl Allergy Ultratab 25 MG Oral Tablet | SY | 7c8b3e05-bdd5-46d3-8ff4-ea6e1f188549 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-226-12 | 50580022612 | 1 BLISTER PACK in 1 CARTON (50580-226-12) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2025-06-11 | No | No | Current | |
| 50580-226-20 | 50580022620 | 2 CARTON in 1 CARTON (50580-226-20) / 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE | 2 carton | 2024-01-15 | No | No | Current | |
| 50580-226-33 | 50580022633 | 3 CARTON in 1 CARTON (50580-226-33) / 1 BOTTLE in 1 CARTON / 48 TABLET, FILM COATED in 1 BOTTLE | 3 carton | 2025-07-28 | No | No | Current | |
| 50580-226-50 | 50580022650 | 1 BOTTLE in 1 CARTON (50580-226-50) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2012-06-04 | 0000-00-00 | No | No | Current |
| 50580-226-51 | 50580022651 | 2 BLISTER PACK in 1 CARTON (50580-226-51) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-06-04 | 0000-00-00 | No | No | Current |
| 50580-226-52 | 50580022652 | 4 BLISTER PACK in 1 CARTON (50580-226-52) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 4 blister pack | 2012-06-04 | 0000-00-00 | No | No | Current |
| 50580-226-53 | 50580022653 | 2 TABLET, FILM COATED in 1 POUCH (50580-226-53) | 2012-06-04 | 0000-00-00 | No | No | Current | |
| 50580-226-54 | 50580022654 | 60 POUCH in 1 CARTON (50580-226-54) / 2 TABLET, FILM COATED in 1 POUCH | 60 pouch | 2015-07-27 | 0000-00-00 | No | No | Current |
| 50580-226-56 | 50580022656 | 3 CARTON in 1 PACKAGE (50580-226-56) / 4 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 3 carton | 2013-02-01 | 0000-00-00 | No | No | Current |
| 50580-226-62 | 50580022662 | 4 POUCH in 1 CARTON (50580-226-62) / 2 TABLET, FILM COATED in 1 POUCH | 4 pouch | 2017-01-02 | 0000-00-00 | No | No | Current |
| 50580-226-70 | 50580022670 | 1 BOTTLE in 1 CARTON (50580-226-70) / 48 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-06-02 | No | No | Current |