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 |
|---|---|---|---|---|---|---|
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | Warnings | M012 |
| Panadol Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 341761b9-f0be-f816-e063-6394a90a5e63 | 2026-04-29 | Warnings | M012 |
| Panadol Cold and Flu Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3417993d-8e3c-23d6-e063-6394a90a7d50 | 2026-04-29 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 509f233e-ff01-8927-e063-6394a90a9929 | 2026-04-29 | Warnings | M012 |
| Broncomiel Adults | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 509c61d3-ae16-be5c-e063-6294a90a68da | 2026-04-29 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | TOP CARE (Topco Associates LLC) | aa1eb90c-e565-455f-8978-6f2f9e00a814 | 2026-04-29 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | e1280355-da81-489f-9bd2-ffea9a68010c | 2026-04-29 | Warnings | M012 |
| Mucus Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | 7b095ec5-9951-4491-9b68-7ac0a7f10053 | 2026-04-29 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOP CARE (Topco Associates LLC) | 98dd0ba6-0109-46b2-92df-11a030984240 | 2026-04-28 | Warnings | M012 |
| Pain, Headache and Congestion | ACETAMINOPHEN, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 41a77cbb-6a4d-46a4-ab27-c7affa2cc682 | 2026-04-28 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | dd7da15a-4e0b-405f-e053-2995a90a06d2 | 2026-04-28 | Warnings | M012 |
| CAREONE CHILDRENS COLD COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Retail Business Services, LLC | 382f7d51-ceb8-4bdf-9bd5-440b50c65cd3 | 2026-04-28 | Warnings | M012 |
| Cold and Flu Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 2026-04-27 | Warnings | M012 |
| Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kroger | 49a7cd2a-8c0e-2196-e063-6294a90a134a | 2026-04-27 | Warnings | M012 |
| Guaifenesin,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | M012 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN | Softgel Healthcare Pvt Ltd | 353ef34f-760d-ae92-e063-6294a90a5b4a | 2026-04-27 | 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 |