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 |
|---|---|---|---|---|---|---|
| TopCare Chest Congestion Relief | GUAIFENESIN | TOPCO ASSOCIATES LLC | b8339617-17ce-4ad7-af38-399ecc74d864 | 2024-12-18 | Warnings | M012 |
| Kroger Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | THE KROGER CO | 976bfdcf-2110-486c-aa6e-cd2067334cdc | 2024-12-18 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | AmerisourceBergen Drug Corp | 79cefd46-bd19-4a1d-9cb1-e85ff0f12494 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Cardinal Health | 8397e1b9-e83e-4c6a-b858-1663c2365840 | 2024-12-18 | Warnings | M012 |
| GNP Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | AmerisourceBergen Drug Corp | 63932e68-b09d-4500-bc1d-cfb2c267df1c | 2024-12-18 | Warnings | M012 |
| Meijer Chest Congestion Relief | GUAIFENESIN | Meijer Distribution Inc. | ae02e0bd-d9e7-495f-b01f-b135b96934a0 | 2024-12-18 | Warnings | M012 |
| Topcare Chest Congestion and Sinus Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | TOPCO ASSOCIATES LLC | b6c0362f-86ca-4f08-ba53-800c6df2c025 | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 10cad9a7-1223-470c-9027-807891217d40 | 2024-12-18 | Warnings | M012 |
| Kroger Mucus Relief | GUAIFENESIN | THE KROGER CO | 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | 41f88b43-3e0a-4650-b167-a72afe6177e8 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Rugby Laboratories | 5da36516-9f94-49cb-9421-0c310abcd116 | 2024-12-18 | Warnings | M012 |
| Kroger Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | THE KROGER CO | 430c6604-93a7-4df6-a657-ba438aa61425 | 2024-12-18 | Warnings | M012 |
| Discount Drugmart Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart, Inc | 1ac281e1-22ea-42f8-98fe-ab3d5ff9a208 | 2024-12-18 | Warnings | M012 |
| TopCare Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 4c50233e-1dcb-427d-ba63-1538cf370061 | 2024-12-18 | Warnings | M012 |
| Dollar General Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Dolgencorp, LLC | 718f08d2-3757-4f3e-915e-3e4982ad090f | 2024-12-18 | Warnings | M012 |
| Good Neighbor Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | AmerisourceBergen Drug Corp | e4610d53-4459-43a0-9351-f0ac8586df60 | 2024-12-18 | Warnings | M012 |
| Always Save Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | Valu Merch | 5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6 | 2024-12-17 | Warnings | M012 |
| Chestrub | CAMPHOR MENTHOL EUCALYPTUS OIL | Delta Brands Inc | 8e6f731f-c16a-41b2-9786-0cab588cfc8e | 2024-12-17 | Warnings | M012 |
| Mentholatum Nighttime Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 5539ae74-9723-480d-b35f-0a6644bf54ad | 2024-12-17 | Warnings | M012 |
| Mentholatum No Mess Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | f4675bc1-01cc-4a33-a3bf-bfc99230fe32 | 2024-12-17 | 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 |