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 |
|---|---|---|---|---|---|---|
| Mentholatum Cherry Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | de01225a-eabb-4972-bf3a-3e5a0e44abef | 2024-12-17 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Rite Aid Corporation | 198a666a-3f34-4e4f-89e8-ec7f412f00af | 2024-12-17 | Warnings | M012 |
| Equate Childrens Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 372e66a6-1f1f-4aa3-a2ed-d215fafee9b9 | 2024-12-17 | Warnings | M012 |
| Caring Mill Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | FSA Store Inc. | caa83419-c332-4b92-b151-22da2fa85289 | 2024-12-17 | Warnings | M012 |
| Always Save Chest Congestion Relief GUAF | GUAIFENESIN | Valu Merch | 9d81d88b-2db9-4891-942b-fecb1be961dd | 2024-12-17 | Warnings | M012 |
| Kroger EXTRA STRENGTH Acetaminophen PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | 24a75ffa-c2a7-71a9-e063-6394a90a0e25 | 2024-12-17 | Warnings | M012 |
| Allergy 36ct, Caseys 4good | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store Products, Inc. | 04b78b23-424d-9762-e063-6394a90a52e3 | 2024-12-16 | Warnings | M012 |
| Sinus Relief, Caseys 4good | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store Products, Inc. | 033837c0-fa68-a38d-e063-6394a90a9832 | 2024-12-16 | Warnings | M012 |
| DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | cfab9b80-0580-4482-b6e3-0aab875b5797 | 2024-12-16 | Warnings | M012 |
| Allergy Relief, 24-7 Lift by 7-Eleven | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store products, Inc. | 04c9db9a-95ef-3a48-e063-6294a90a4e8e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Daytime Severe, 24/7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET | Lil' Drug Store Products, Inc. | 05cc7185-d49d-82a3-e063-6294a90a568e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | M012 |
| tussin dm max daytime nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN | CVS Pharmacy | 6feaf29e-de06-4c94-912c-a76ea2cbd8c1 | 2024-12-16 | Warnings | M012 |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | M012 |
| Dextromethorphan HBr 15 mg Liquid Gels | DEXTROMETHORPHAN HBR | RUGBY LABORATORIES | cf3cc387-6642-43fd-999d-688fdaf65d4f | 2024-12-14 | Warnings | M012 |
| Allergy Relief Dye-Free Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 60b1bb79-3ed1-438b-a27f-f7fbc108d114 | 2024-12-14 | Warnings | M012 |
| Rycontuss Cherry Flavor | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Okendpharma, Inc. | c91798fa-48ab-47a0-92da-4d44c2aafde0 | 2024-12-13 | Warnings | M012 |
| Mentholatum Lavender Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 6f208c05-617d-492a-a016-e9d6be3c971f | 2024-12-13 | Warnings | M012 |
| CVS Vapor Steam | CAMPHOR (SYNTHETIC) | CVS | 49da2c40-afc5-5770-e054-00144ff88e88 | 2024-12-13 | 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 |