Dimetane
- Product NDC
- 57237-367
- 11-digit product format
- 572370367
- Labeler code
- 57237
- Product ID
- 57237-367_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 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
- Dimetane
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 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 |
|---|---|---|---|---|---|---|
| 57237-367-01 | Dimetane | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | 1 | |
| 57237-367-99 | 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 |
|---|---|---|---|---|---|
| 57237-367-01 | EA - Each | 57237-367 | e5cbb116-bb64-4ac1-b056-693aaf678377 | 1 | 2026-02-05 |
| 57237-367-99 | EA - Each | 57237-367 | 52918ffe-99b2-4ea2-b110-01ee01c5a25c | 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 |
|---|---|---|---|---|---|---|
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 97554f40-f9aa-4dbf-a6f2-de6197236ab4 | 2026-02-25 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Family Dollar Stores, Inc | 1b50b865-3dfc-4b3f-86d5-5e91ca772445 | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Vaproizing | CAMPHOR | H E B | 577fda09-588a-4c2e-ada5-eeda32d1aabe | 2026-02-24 | Warnings, Adverse reactions | M012 |
| Sore Throat Logenzes Sore Throat | BENZOCAINE AND MENTHOL | Major Pharmaceuticals | 11416620-4892-44ba-9780-db27efff6743 | 2026-02-24 | Warnings | M012 |
| Family Wellness SF Honey Lemon Cough Drops | MENTHOL | Family Dollar | 4437853d-1f42-a41d-e063-6294a90aa81e | 2026-02-24 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 64a93715-e7b1-4de1-8099-8ad6c585d517 | 2026-02-24 | Warnings | M012 |
| Cough and Chest Congestion DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 86af74c2-9183-4ee9-ad1e-d88dfc8bf47d | 2026-02-24 | Warnings | M012 |
| Cough DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 39adf23e-76f3-42e1-a9f4-55feb38078e5 | 2026-02-24 | Warnings | M012 |
| Revasol Tussin DM Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Rnv LLC | 4b7fd320-2f39-fa1a-e063-6294a90ada9e | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Allergy | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 47317865-4310-4f07-8815-f3130963307d | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE | Foundation Consumer Brands | 42720fa0-fcdd-4614-80b2-16d0ada345b1 | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | cc09a8c5-d173-4261-b838-96e6a16e2ff9 | 2026-02-23 | Warnings | M012 |
| Dimetapp Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Foundation Consumer Brands | 96a1055f-e831-4f4b-8af3-7a41838c194c | 2026-02-23 | Warnings | M012 |
| Dimetapp Cold and Cough and Nighttime Cold and Congestion | DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Foundation Consumer Brands | 1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246 | 2026-02-23 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Better Living Brands, LLC | 0948648c-1c5f-4225-a754-120ca8859f19 | 2026-02-23 | Warnings, Adverse reactions | M012 |
| Revasol Tussin | GUAIFENESIN | Rnv LLC | f66dc593-9023-40e8-9cc3-0380b04b4305 | 2026-02-23 | Warnings | M012 |
| Equate Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 3006971b-784c-43fd-91a6-d96876bbf185 | 2026-02-23 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 04e70311-6412-4a20-84e3-f6e26d5f19ab | 2026-02-20 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 2026-02-20 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | dca04d80-e781-40b1-e053-2995a90a7010 | 2026-02-20 | 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 |
|---|---|---|---|---|---|---|
| 57237-367-01 | 57237036701 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-01) | 2026-01-27 | No | No | Current |
| 57237-367-99 | 57237036799 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99) | 2026-01-27 | No | No | Current |