Banophen
- Product NDC
- 0904-5307
- 11-digit product format
- 009045307
- Labeler code
- 0904
- Product ID
- 0904-5307_4b4333df-2739-654b-e063-6394a90a4a1d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hcl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-11-02
- Marketing end
- 2028-01-31
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0904-5307 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 0904-5307 | 0904-5307-60 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 0904-5307 | 0904-5307-80 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-5307-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-5307-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-5307-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-5307-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0904-5307-80 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0904-5307-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0904-5307-80 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0904-5307-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0904-5307-80 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0904-5307-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0904-5307-80 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0904-5307-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0904-5307-80 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0904-5307-60 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0904-5307-80 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0904-5307-60 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0904-5307-80 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0904-5307-60 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0904-5307-80 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0904-5307-60 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0904-5307-80 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0904-5307-60 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0904-5307-80 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0904-5307-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 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 |
|---|---|---|---|---|---|---|
| 0904-5307-60 | Banophen | 100 in 1 BOTTLE | CAPSULE | 100 | 10 | |
| 0904-5307-80 | Banophen | 1000 in 1 BOTTLE | CAPSULE | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5307-60 | EA - Each | 0904-5307 | fbc100c3-1d2e-4360-bd2f-a92b1e556d3b | 1 | 2013-02-11 |
| 0904-5307-80 | EA - Each | 0904-5307 | 602b6862-e0e7-4d9b-bcb4-48a7a3eba316 | 1 | 2013-02-11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | d0f4b9f4-e727-4d47-b156-7bcdcb1606da | 106 |
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 20f00537-2c8a-45d1-8e5f-ec276d0a47b6 | 11 |
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 10 |
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 0e06dca9-485a-4367-bcfa-07e0cc27c128 | 7 |
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 0f52270a-b11a-4fa1-aac2-9fe5ff625419 | 5 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | ea0c7005-3122-4ff4-8bc1-dda8116803c1 | 4 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | ea0c7005-3122-4ff4-8bc1-dda8116803c1 | 4 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | ea0c7005-3122-4ff4-8bc1-dda8116803c1 | 4 |
| 1020479 | BANOPHEN 50 MG Oral Capsule | PSN | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1020479 | diphenhydramine hydrochloride 50 MG Oral Capsule [Banophen] | SBD | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1020479 | Banophen 50 MG Oral Capsule | SY | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | d4ec6dfd-61b0-7153-e053-2995a90ad88f | 2 |
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 1e01f8b8-ca29-902e-e063-6394a90a4cb8 | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 1e01f8b8-ca29-902e-e063-6394a90a4cb8 | 1 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 1e01f8b8-ca29-902e-e063-6394a90a4cb8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-5307-60 | 00904530760 | 100 CAPSULE in 1 BOTTLE (0904-5307-60) | 100 capsule | 2009-11-02 | 2028-01-31 | No | No | Current |
| 0904-5307-80 | 00904530780 | 1000 CAPSULE in 1 BOTTLE (0904-5307-80) | 1000 capsule | 2009-11-02 | 2028-01-31 | No | No | Current |