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 | 2026-10-15 | ||
| excluded package | package | 0904-5307 | 0904-5307-60 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0904-5307 | 0904-5307-80 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Kids Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4 | 2026-05-08 | Warnings | M012 |
| day time non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | f4fd597f-bca2-4ed4-b353-6c734f2f885c | 2026-05-08 | Warnings | M012 |
| Daytime Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | d8339bb0-5da3-4f34-a819-339643cf4a97 | 2026-05-08 | Warnings | M012 |
| severe tussin cf | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | a26afc33-533e-4dc0-ab25-21be87356e22 | 2026-05-08 | Warnings | M012 |
| SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | cdd53eba-1fa2-49c1-b03d-c32f309da7fb | 2026-05-08 | Warnings | M012 |
| Benadryl Allergy Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | bfeae100-e2d1-4607-be3b-2d9b15cd4f7f | 2026-05-07 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | H E B | 6503761f-37ae-4f39-b727-cb75d4c4a3c9 | 2026-05-07 | Warnings, Adverse reactions | M012 |
| Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | ad199488-a4be-4b6e-b806-67ce8a6e907e | 2026-05-07 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HCL | L. Perrigo Company | 5d42adb9-3625-4072-a6b1-29a229f255c8 | 2026-05-07 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 4856cd7b-ccdf-4546-9c65-236ebaac3dca | 2026-05-06 | Warnings | M012 |
| Mucus Relief All in One Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac | 2026-05-06 | Warnings | M012 |
| daytime cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 175cc2d0-0202-4e38-8af2-9fc126b7412d | 2026-05-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 90fae0fa-da07-4ea8-bdbd-39c2ed99ae59 | 2026-05-06 | Warnings | M012 |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | HHH Pharmaceuticals | 5d8b980f-0011-41e3-a881-ad10fe399079 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 38d12374-e2c7-444c-e063-6294a90a42b3 | 2026-05-06 | Warnings | M012 |
| HALLS Mentholyptus | MENTHOL | Mondelez Global LLC | 1ab295ff-94b1-c938-e063-6294a90a98fd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | M012 |
| Thieves Chest Rub | CHEST RUB | Young Living Essential Oils, LC. | 9b7f125e-6caa-c53e-e053-2a95a90a737e | 2026-05-06 | Warnings | M012 |
| Maximum Strength Mucus Relief Plus Pain and Headache | ACETAMINOPHEN, GUAIFENESIN | Shield Pharmaceuticals Corp | f20c0db1-dcf3-4bfc-b3e4-930398f82dc9 | 2026-05-06 | Warnings | M012 |
| Nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 8aa6492b-1723-4c6b-82ee-4f800301c6ad | 2026-05-06 | 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 |