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 |
|---|---|---|---|---|---|---|
| Sinus Congestion | PHENYLEPHRINE HCL | L.N.K. International, Inc. | 81f0276a-99a2-4a57-a0d8-224735aa8c79 | 2026-07-10 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rite Aid Corporation | efaf3be1-ab39-45f7-a45c-7fea8705c8d0 | 2026-07-10 | Warnings | M012 |
| Equate Daytime Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | f847d9f2-aa47-4bbe-8f06-19356c637398 | 2026-07-10 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 2a80fba9-5e30-4ec0-bd8e-8957c0654b6c | 2026-07-10 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50230cad-3d04-8882-e063-6294a90acf3c | 2026-07-09 | Warnings | M012 |
| Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rugby Laboratories | fc42e97d-1224-4d29-a55d-1a1885e0bf8f | 2026-07-09 | Warnings | M012 |
| Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 7418d92d-a540-40d6-91d0-b7eb1f87f8ff | 2026-07-08 | Warnings | M012 |
| DG HEALTH COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d | 2026-07-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Topco Associates, LLC | bfcabe02-7961-4407-a748-8cd087731398 | 2026-07-08 | Warnings | M012 |
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | M012 |
| nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 24c22c9f-0c2f-46dc-850e-ed05f00d3e95 | 2026-07-08 | Warnings | M012 |
| NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 0e65c5d1-a18b-452c-9be6-8d44d34577e9 | 2026-07-08 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Cardinal Health 110, LLC. DBA Leader | aaecfda5-1a50-4d8a-9909-7153c1a22bda | 2026-07-08 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7cb9f378-5d64-475f-bf26-4058ba6c15b4 | 2026-07-08 | Warnings | M012 |
| DG HEALTH DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | f174d08e-3335-4cc9-8766-4070f18c4f31 | 2026-07-08 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN 400 MG | Health Pharma USA LLC | d60a3e9d-e88e-3b19-e053-2995a90a3e8d | 2026-07-07 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Health Pharma USA LLC | d38f47ea-7fda-170b-e053-2995a90adc82 | 2026-07-07 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Health Pharma USA LLC | d68222f7-b796-7b27-e053-2995a90a2efe | 2026-07-07 | Warnings | M012 |
| Cold and Flu Severe Day Time / Night Time | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | acdcc6ce-c190-4de6-b126-62fe9043112e | 2026-07-07 | Warnings | M012 |
| Calmco Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 471b1a43-1708-8be7-e063-6394a90a9bb7 | 2026-07-06 | 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 |