Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Product NDC
- 83586-004
- 11-digit product format
- 835860004
- Labeler code
- 83586
- Product ID
- 83586-004_5535342f-6ec5-edd2-e063-6294a90ad37e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HHH Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-27
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 12.5; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [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
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1233575 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 265f1ce7-160c-4dda-b2e0-b78d68f962bd | 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 |
|---|---|---|---|---|---|---|
| Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE 25MG | Walgreens | 36ba3ff2-1965-aa56-e063-6294a90afe17 | 2025-12-31 | Warnings | M012 |
| Sinus Congestion and Pain Severe | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Wal-Mart Stores Inc | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 2025-12-31 | Warnings | M012 |
| Durahist | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 33d71863-5cac-669f-e063-6394a90a6f21 | 2025-12-30 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | RUGBY LABORATORIES | 51b088bc-b44f-44b9-a08e-133509a35a2c | 2025-12-30 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | RUGBY LABORATORIES | 60c9e493-f58c-45d6-bade-c95297512403 | 2025-12-30 | Warnings | M012 |
| BIO-RYTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Advanced Generic Corporation | e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b | 2025-12-30 | Warnings | M012 |
| Altituss | DEXTROMETHORPHAN HBR, GUAIFENESIN | Alternative Pharmacal Corporation | e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44 | 2025-12-30 | Warnings | M012 |
| Biocof | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL | Advanced Generic Corporation | 6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6 | 2025-12-30 | Warnings | M012 |
| Altipres Pediatric | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Advanced Generic Corporation | 2a336896-a2f8-2a0c-e063-6294a90ae03a | 2025-12-30 | Warnings | M012 |
| Altipres | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Alternative Pharmacal Corporation | c5a43107-3eb8-46bb-87bd-20deafe28c3f | 2025-12-30 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association, Inc. | d02f32c1-716e-4753-abba-ff97c4dc9e22 | 2025-12-30 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a690f5c5-ff41-4072-e053-2995a90a8e55 | 2025-12-29 | Warnings | M012 |
| Ninjacof | CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE | Centurion Labs, LLC | e2bca40f-9c27-ec8b-2ff0-ef9847ba2037 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23079194-b5e7-d5e6-e063-6394a90a4d8c | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307db15-592b-138a-e063-6394a90a23a5 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Vanilla Honey | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23087ee3-26a0-e2b8-e063-6394a90abef4 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 230883da-de48-68e9-e063-6394a90a927c | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23086723-5718-6d02-e063-6394a90a03d2 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Creamy Strawberry | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23085717-b2ee-175c-e063-6394a90a7f54 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307bbe9-7c8f-4eff-e063-6394a90af4c3 | 2025-12-29 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83586-004-00 | 83586000400 | 32000 TABLET, FILM COATED in 1 BOTTLE (83586-004-00) | 2026-06-27 | No | No | Current |