Banophen
- Product NDC
- 0904-7672
- 11-digit product format
- 009047672
- Labeler code
- 0904
- Product ID
- 0904-7672_3a7e89bb-8a02-4fe1-9fd9-821f403a10b3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-15
- 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
- Banophen
- 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 |
|---|---|
| 519abfcd-b50b-302e-e063-6394a90ade20 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| PECGEN DMX | DEXTROMETHORPHAN HBR, GUAIFENESIN | KRAMER NOVIS | a627824c-5e3d-4672-a047-6c801b50b432 | 2025-11-14 | Warnings | M012 |
| Supress DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | KRAMER NOVIS | 7da0611e-729c-4cf8-88f3-f8877b9f5cfa | 2025-11-14 | Warnings | M012 |
| G-ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc | 2025-11-14 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | PD-Rx Pharmaceuticals, Inc. | c1873a4c-661f-4896-bcc0-f6d3a655de94 | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | M012 |
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | M012 |
| Robitussin Maximum Strength Severe Cough Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 6a6f5da8-6433-4284-8df7-2d5b099b74dc | 2025-11-13 | Warnings | M012 |
| equaline allergy | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 8e4eb1eb-5b55-4531-94d2-998425ec80ed | 2025-11-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | 7a78f24b-7c23-4318-99dc-90c05db185b1 | 2025-11-13 | Warnings | M012 |
| ZYNCOF | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Kramer Novis | cffd6d5f-0cb2-4d38-bdb0-6a21120418cc | 2025-11-13 | Warnings | M012 |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b6da1659-8c79-4cce-a817-907a7f061a2d | 2025-11-13 | Warnings | M012 |
| Tussi Pres | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | 0d4ee530-2a5c-41a0-88bf-ac92d538661b | 2025-11-12 | Warnings | M012 |
| 4 Way Fast Acting | PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | a8fc41c7-4425-41b8-b1c6-eb22ac054734 | 2025-11-12 | Warnings | M012 |
| Quality Choice Vapor Steam | CAMPHOR (SYNTHETIC) | Chain Drug Marketing Association, Inc. | 1f1e6be5-d407-330c-e063-6294a90a4e80 | 2025-11-12 | Warnings | M012 |
| G-Supress DX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5dd44337-f3aa-4e73-a206-4a29850a2f7c | 2025-11-12 | Warnings | M012 |
| Allergy Relief Complete | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 15b3de6c-7ccc-408b-8789-d0e2f21a8835 | 2025-11-12 | Warnings | M012 |
| PRESGEN PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 2025-11-12 | Warnings | M012 |
| Sorbugen | DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE | Kramer Novis | a8f2a2d7-0360-45a8-9635-c852f4a7d7ba | 2025-11-12 | Warnings | M012 |
| DESGEN DM | DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL | Kramer Novis | 6ab47174-e1fd-47ce-8788-06b7cdad5218 | 2025-11-12 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0904-7672-24 | 00904767224 | 24 BLISTER PACK in 1 CARTON (0904-7672-24) / 1 CAPSULE in 1 BLISTER PACK | 24 blister pack | 2026-10-15 | No | No | Current |
| 0904-7672-60 | 00904767260 | 100 CAPSULE in 1 BOTTLE (0904-7672-60) | 100 capsule | 2026-10-15 | No | No | Current |
| 0904-7672-61 | 00904767261 | 100 BLISTER PACK in 1 CARTON (0904-7672-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2026-10-15 | No | No | Current |
| 0904-7672-80 | 00904767280 | 1000 CAPSULE in 1 BOTTLE (0904-7672-80) | 1000 capsule | 2026-10-15 | No | No | Current |