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 |
|---|---|---|---|---|---|---|
| Pharbinex-PE | GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG | Ulai Health LLC | e459bb83-b1d6-42fc-aa46-99ad117e6144 | 2025-01-20 | M012 | |
| Pharbinex-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Ulai Health LLC | af80d10e-3fb2-405a-a803-1f876b8dcd10 | 2025-01-20 | M012 | |
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 |
| daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | df31056b-d0eb-4094-98d9-3d444210d50d | 2025-01-16 | Warnings | M012 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Reliable 1 Laboratories LLC | 28dd9baa-43bd-b60a-e063-6394a90a8cf7 | 2025-01-15 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCL 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32f58cb3-941f-263b-e054-00144ff8d46c | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCl 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32fa40ad-fed5-586f-e054-00144ff88e88 | 2025-01-15 | Warnings | M012 |
| CVS Health Chest Congestion and Cough HBP SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy, Inc | 2741ba44-1cc7-1812-e063-6394a90a8faa | 2025-01-14 | Warnings | M012 |
| DAY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 2b941963-8a8c-4148-e063-6294a90a1dfb | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 437e6a13-a4ff-4f98-8973-042f224ee85e | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 6a520986-1004-4ee6-9a47-1dfd90bb1b2c | 2025-01-13 | Warnings | M012 |
| good sense daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 5ddf3283-94e4-465d-842a-471ee946c330 | 2025-01-10 | 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 |