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 |
|---|---|---|---|---|---|---|
| MUCOSA | GUAIFENESIN | TIME CAP LABORATORIES,INC | d34ef2e8-adc2-48e5-a572-e354937daec6 | 2023-11-02 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 09286d15-b63f-a9de-e063-6294a90ab948 | 2023-11-02 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | f6cece6c-23e4-7811-e053-6394a90a106a | 2023-11-02 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | eb64750f-19ac-655f-e053-2995a90a33b5 | 2023-11-02 | Warnings | M012 |
| Multi-Symptom Mapap Cold Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Proficient Rx LP | 9bf81b26-38b4-486c-ae89-222119ce1a4f | 2023-11-01 | Warnings | M012 |
| Guaifenesin Syrup and Dextromethorphan | GUAIFENESIN SYRUP AND DEXTROMETHORPHAN | Natco Pharma USA LLC | ad9026f4-f0b6-4d02-aa44-f0460eeefc0e | 2023-11-01 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HYDROCHLORIDE | Natco Pharma USA LLC | 54b64354-ac10-42ff-a53d-96cef933a91a | 2023-11-01 | Warnings | M012 |
| children allergy relief dye free cherry | DIPHENHYDRAMINE HCL | A-S Medication Solutions | 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 | 2023-11-01 | Warnings | M012 |
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0903b222-1a44-64aa-e063-6294a90abba0 | 2023-10-31 | Warnings | M012 |
| Ephrine Nose Drops | PHENYLEPHRINE HYDROCHLORIDE | Walgreens | b620eb9f-2caf-0942-e053-2a95a90ae48e | 2023-10-31 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 204849d1-ac4b-4dbe-8769-fcb30291f880 | 2023-10-31 | Warnings | M012 |
| Daytime Cold and Flu Relief | DAYTIME COLD AND FLU RELIEF | TopCo Associates, LLC | d592fbb8-d4bf-444e-982e-edf6fe97dce4 | 2023-10-31 | Warnings | M012 |
| Nite Time Cold and Flu Relief | NITE TIME COLD AND FLU RELIEF | TopCo Associates, LLC | 407dc4ae-882d-4a49-8884-ef048bb404cf | 2023-10-31 | Warnings | M012 |
| 12 Hour Original Nasal Decongestant | NASAL SPRAY | Sheffield Pharmaceuticals LLC | cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 | 2023-10-30 | Warnings | M012 |
| Mucosa DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Magno-Humphries, Inc. | 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f | 2023-10-27 | Warnings | M012 |
| Mucosa Guifenesin | GUAIFENESIN | Magno-Humphries, Inc. | 9d22c208-d0ae-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M012 |
| DG Health Cough Drops Cherry Flavor | MENTHOL | Dollar General Corporation | c7a603d8-72fb-9626-e053-2995a90a09ea | 2023-10-26 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | Geri-Care Pharmaceutical Corp | 92d90b41-0627-121e-e053-2995a90a2df1 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Cherry | MENTHOL | Riclan S.A. | 8e471265-3594-451a-8921-f0db474abe85 | 2023-10-26 | Warnings | M012 |
| Freegells Cough Drops Menthol Eucalyptus | MENTHOL | Riclan S.A. | 1141593a-f3ba-4adf-b332-f9fcb0b5a013 | 2023-10-26 | 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 |