Dimetane
- Product NDC
- 57237-367
- Requested package NDC
- 57237-367-99
- 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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORP | 0b1e230d-4354-bf61-e063-6394a90a2b2f | 2023-12-09 | Warnings | M012 |
| Phenylephrine HCl Maximum Strength | PHENYLEPHRINE HCL | A-S Medication Solutions | fcb769d0-aa45-48eb-acd0-2247b392f9fe | 2023-12-09 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf915af-a016-0a46-e063-6394a90aacf5 | 2023-12-08 | Warnings | M012 |
| Maximum Strength Daytime Severe and Nighttime Cold and Flu | DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI | TARGET Corporation | 0bf9c0df-7676-3060-e063-6394a90a16c7 | 2023-12-08 | Warnings | M012 |
| Nazal | NAPHAZOLINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 4d4043f8-5ed3-4027-beb6-687db1308202 | 2023-12-06 | Warnings | M012 |
| Family Wellness Oxymetazoline | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 8b4557d4-74a0-400f-ad7a-6d31473b3c67 | 2023-12-06 | Warnings | M012 |
| Childrens Plus Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1598e6f8-08ee-4216-a5ab-76cad37b09a7 | 2023-12-06 | Warnings | M012 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf | 2023-12-05 | Warnings | M012 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Relief | PETROLATUM, ZINC OXIDE | Welmedix LLC | 551e6cce-7adc-4e98-baff-2703b83d7526 | 2023-12-05 | Warnings | M012 |
| Stona-S | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 2023-12-04 | Warnings | M012 |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | afc95c82-18da-487b-b4bb-51e0be0378da | 2023-12-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | a14643a1-3d91-491a-88d6-22dccde97938 | 2023-12-04 | Warnings | M012 |
| TopCare Day Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 14d53907-a4a2-4a0f-b2d6-33474945f9e1 | 2023-12-04 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Proficient Rx LP | 62934d0f-b23d-4c03-9d60-a7bad41f9b42 | 2023-12-01 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | b1c849e5-8003-4fd3-811d-6a927523e353 | 2023-12-01 | Warnings | M012 |
| Akin Expectorant Formula Strawberry Banana | GUAIFENESIN | Southern Sales & Service, Inc. | b63b0133-d2da-432b-a154-9e77535bbef9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM Strawberry Banana | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Southern Sales & Service, Inc. | 7a81efd8-775d-455e-860f-f3e3b369a0a7 | 2023-11-29 | Warnings | M012 |
| Akin | GUAIFENESIN | Southern Sales & Service, Inc. | bb2c9f21-6765-4286-bd71-de01cdf4c4e9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM | DEXTROMETHORPHAN, GUAIFENESIN | Southern Sales & Service, Inc. | 1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a | 2023-11-29 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Simpex Pharma Pvt. Ltd | 82771f6a-8b3d-4ffa-8b35-09c2faf3582c | 2023-11-29 | 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 |
|---|---|---|---|---|---|---|
| 57237-367-99 | 57237036799 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99) | 2026-01-27 | No | No | Current |