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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walmart Inc. | 35da8429-1f83-9e81-e063-6294a90a3515 | 2025-05-23 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9dfef3dc-dbc8-659a-e053-2995a90a8c3b | 2025-05-21 | Warnings | M012 |
| Adult Tussin | GUAIFENESIN | Camber Consumer Care | 896d2540-279a-4405-b176-acbff56303e5 | 2025-05-20 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 37a88914-6234-4191-86f5-103c396c52af | 2025-05-20 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | 1ea15426-4f3d-4a97-a590-6bd73bc6cbcd | 2025-05-19 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 812a093f-cf83-4f7a-927a-1b5695be7f90 | 2025-05-19 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | SDA Laboratories, Inc. | 1fd16b06-0c3e-4a30-ae6a-7b1632189c20 | 2025-05-16 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 79a6b8c7-0e81-4a46-a854-31f449042709 | 2025-05-16 | Warnings | M012 |
| Tussin DM Sugar free | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AARNA USA, Inc. | 3a521b65-fb35-4cc3-b826-88513afda0f9 | 2025-05-16 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 51c7628a-c7cf-498f-8fb1-db732e2b8b6e | 2025-05-16 | Warnings | M012 |
| BACTIMICINA CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | DLC Laboratories, Inc. | eaf554d4-a758-4ed6-bec5-d6cbfedae408 | 2025-05-15 | Warnings | M012 |
| Bactimicina Childrens Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | DLC Laboratories, Inc. | d407a583-07ae-4d47-b15a-24b5865c82da | 2025-05-15 | Warnings | M012 |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | RB Health (US) LLC | 35322238-d498-1a52-e063-6394a90ac9c4 | 2025-05-15 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | a1405038-80f2-45e5-bd8c-8c6b0ee348be | 2025-05-15 | Warnings | M012 |
| Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | b919f0fe-fae0-4bd8-9ccd-d7569b2a7070 | 2025-05-13 | Warnings | M012 |
| Childrens Robitussin Honey Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 6afaf85b-bf0c-4c99-acf3-a34f06be20f1 | 2025-05-13 | Warnings | M012 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 77be57fb-0ae5-4fad-97f3-b6a4b57383a9 | 2025-05-13 | Warnings | M012 |
| Maximum Strength Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | c3d0b70f-d213-4e38-88ab-1c89d93a391d | 2025-05-10 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Safeway, Inc. | c639a36d-c683-4a4d-90b7-eadec7464aa2 | 2025-05-08 | Warnings | M012 |
| Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645 | 2025-05-07 | 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 |