Dimetane
- Product NDC
- 57237-368
- 11-digit product format
- 572370368
- Labeler code
- 57237
- Product ID
- 57237-368_958e9dae-4d1c-40fc-b84d-20f2ed6996c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-27
- Substance
- DIPHENHYDRAMINE
- Active strength
- 50 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
- Dimetane
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8GTS82S83M | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57237-368-01 | Dimetane | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 1 | |
| 57237-368-99 | Dimetane | 1000 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 1000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57237-368-01 | EA - Each | 57237-368 | 62baf022-bbe0-43a6-bcdb-9b2d3e9c6daf | 1 | 2026-02-05 |
| 57237-368-99 | EA - Each | 57237-368 | 76cfcca6-6cfb-4b60-bdf6-be4ef61ca117 | 1 | 2026-02-05 |
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 Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | dbc71f58-0704-4d2b-aed1-0dc01f980006 | 2024-06-11 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | 135d2212-2122-b7a1-e063-6294a90aa5f5 | 2024-06-07 | Warnings | M012 |
| up and up daytime honey cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | 29da4b94-8f8e-48e8-909f-8476e3b39d78 | 2024-06-06 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | TARGET Corporation | e3da3003-88e3-4431-8b65-e61e17728901 | 2024-06-04 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE | Foundation Consumer Healthcare | 15c3570c-bd00-8e43-e063-6294a90a8683 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 176be362-5237-edd8-e063-6294a90a4aef | 2024-06-01 | Warnings | M012 |
| Dimetapp Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE | Foundation Consumer Healthcare | 179115ad-d610-99b2-e063-6294a90ae711 | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Cough | DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Healthcare | 179259a9-231e-df03-e063-6294a90a145e | 2024-06-01 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough | BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Healthcare | 1820e7c7-bc11-9061-e063-6394a90ae581 | 2024-06-01 | Warnings | M012 |
| Theraflu Severe Cold Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 682c5a4b-5ded-4276-903f-1ef1141ae518 | 2024-06-01 | Warnings | M012 |
| Maximum Strength Nasal Decongestant | OXYMETAZOLINE SPRAY | CVS Health | df1f8bda-7bf3-4755-9169-f2a81d824cbe | 2024-05-31 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | a78d29ed-019b-4014-ae6f-c60c75d19c89 | 2024-05-31 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 6594c117-6ffc-4bda-8bbf-e91c810f2c3f | 2024-05-31 | Warnings | M012 |
| Nighttime Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 1aba9b7c-8328-4a9f-8ce2-39648b2d8ae4 | 2024-05-23 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | fdf63308-fe7b-4613-a012-ed5e4c9f8ffe | 2024-05-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | e61ab02d-f932-403f-a4f7-0ca354607223 | 2024-05-23 | Warnings | M012 |
| Daytime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | e4f9a846-ab72-4508-b0c5-f7911af2f3d7 | 2024-05-23 | Warnings | M012 |
| Adult Cough Relief | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c | 2024-05-20 | Warnings | M012 |
| Chlorpheniramine Maleate 4 mg | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | 54681242-c861-4415-b5c0-d3ab55b62be1 | 2024-05-17 | Warnings | M012 |
| Dibromm Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c830b18b-4427-4530-9bc7-85c2735080d2 | 2024-05-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 1 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 1 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 1 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 57237-368-01 | 57237036801 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-01) | 2026-01-27 | No | No | Current |
| 57237-368-99 | 57237036899 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-368-99) | 2026-01-27 | No | No | Current |