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 |
|---|---|---|---|---|---|---|
| Childrens Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 9aca1a68-893c-4770-8a48-d5d678058253 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | d26b5143-aa07-4114-a6ba-4f503aadd46f | 2026-05-27 | Warnings | M012 |
| Goodmeds Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 37533188-8c91-428b-a796-c5afd9e4959f | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 8252cdec-b668-4450-b045-e093479ab542 | 2026-05-27 | Warnings | M012 |
| Delsym Nighttime Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27f9d2db-38ce-41d2-8f1a-0eb171600274 | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Sore Throat | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | b37b786e-0cce-419d-94ed-3b64a1eb1201 | 2026-05-27 | Warnings | M012 |
| Delsym Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | a43d59f9-3a6c-4a7c-b98d-b86d6035f716 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Relief Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 5700ef26-ffa6-480a-bf36-bd5111799e9b | 2026-05-27 | Warnings | M012 |
| Air Power | GUAIFENESIN | Schwabe North America, Inc | 5cdefc7a-6242-4681-88a3-04422a1d48d3 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | adb658c8-db8d-4db6-80c8-e0f2de88a2de | 2026-05-27 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | c71427d4-707f-411f-8bd4-133517a9992b | 2026-05-26 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CVS PHARMACY, INC | 643e929d-9e62-4260-91ee-e88a184dd7cd | 2026-05-26 | Warnings | M012 |
| TopCare Day Time Nite Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | c00ff684-acaf-4fbe-bc74-7e48751b927d | 2026-05-26 | Warnings | M012 |
| Goodmeds Non-Drowsy Nasal Decongestant PE | PHENYLEPHRINE | Cabinet Health P.B.C. | 4e75da23-35f2-431c-92cb-c2c4cb3f09f1 | 2026-05-26 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 13492631-d5de-4562-a201-664f7d3591de | 2026-05-26 | Warnings | M012 |
| Sinufrin Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 52a2e5f9-e0a2-02f7-e063-6294a90a3ae9 | 2026-05-25 | Warnings | M012 |
| Cough Suppressant Adult | DEXTROMETHORPHAN HYDROBROMIDE | Rugby Laboratories | 47b713bd-4c1e-f44a-e063-6294a90a63d3 | 2026-05-25 | Warnings | M012 |
| ClorRelief | CHLORPHENIRAMINE MALEATE | FERRER MEDICAL INNOVATIONS LLC | db729011-f72f-5911-e053-2a95a90a68bf | 2026-05-22 | Warnings | M012 |
| Childrens Dye Free Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c | 2026-05-22 | 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 |