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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vapo Steam | VAPO STEAM | TOPCO ASSOCIATES, LLC | f216f69f-9580-25ac-e053-2995a90a5ac6 | 2026-01-14 | Warnings | M012 |
| Leader Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | f27bf0b2-25cc-474c-ab6b-f227ed3525fa | 2026-01-14 | Warnings | M012 |
| Sinus PE plus Allergy | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Walgreen Company | a15979d4-87bf-42e7-b1f2-783496072141 | 2026-01-13 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | 41f4bf6d-f83c-92e4-e063-6394a90aebab | 2026-01-13 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e608643-1a74-b474-e063-6294a90ad2e0 | 2026-01-13 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 462cbf3d-51b1-dab9-e063-6394a90a70ba | 2026-01-13 | Warnings | M012 |
| Pocket Farmacy | MENTHOL | Saje Natural Business Inc. | 4260542e-0980-4b0b-8177-1c9f2c53b5a6 | 2026-01-13 | Warnings | M012 |
| Sweet Comfort | MENTHOL | Saje Natural Business Inc. | cf13cccd-723d-4d61-8a5e-b36281605cc7 | 2026-01-13 | Warnings | M012 |
| Fortify | MENTHOL | Saje Natural Business Inc. | 0320a305-99d1-4909-94cc-cd6509ecb948 | 2026-01-13 | Warnings | M012 |
| Rolling Farmacy | MENTHOL | Saje Natural Business Inc. | a38765a9-22cd-4fc5-b5ab-c3cacbd52c74 | 2026-01-13 | Warnings | M012 |
| Home Farmacy | MENTHOL | Saje Natural Business Inc. | add35d10-b27a-4ae8-b2de-8a285aaef155 | 2026-01-13 | Warnings | M012 |
| Traveling Farmacy | MENTHOL | Saje Natural Business Inc. | 5b70f5aa-ed36-65ab-e053-2a91aa0a6777 | 2026-01-13 | Warnings | M012 |
| sinus plus allergy PE maximum strength | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 660d3c80-f249-41dd-aa93-a0b1e635ead0 | 2026-01-13 | Warnings | M012 |
| Chest Comfort | MENTHOL | Saje Natural Business Inc. | 8a3db169-6dd7-4dfd-8360-90315288f21b | 2026-01-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | H E B | c9e977b6-fba6-49ea-9d80-b43b0842bbe1 | 2026-01-12 | Warnings | M012 |
| PE Sinus Congestion | PHENYLEPHRINE HCL | Topco Associates, LLC | 3264e291-7a0f-4e25-8390-ba441f22f650 | 2026-01-12 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | 3f44cff6-240a-4a8d-aaa1-0da75a31a47b | 2026-01-12 | Warnings | M012 |
| Suphedrine PE Sinus Congestion Non-Drowsy | PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | b9122fd0-0bed-4302-9bbe-cd6a46d29818 | 2026-01-12 | Warnings | M012 |
| Sinu-Phen Plus Sinus Pain and Pressure | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Wildman Business Group | c66e0b52-5531-4a84-ae90-8a26d27df1ec | 2026-01-12 | Warnings | M012 |
| SU PHEDRINE PE SINUS CONGESTION | PHENYLEPHRINE HCL | Salado Sales, Inc. | ba075ff7-4e26-4856-8335-0c7dd4e198ea | 2026-01-12 | Warnings | M012 |
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 |