Allergy plus Sinus Headache
- Product NDC
- 83059-0162
- 11-digit product format
- 830590162
- Labeler code
- 83059
- Product ID
- 83059-0162_5b3d25c2-6780-4701-e063-6394a90abb19
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-11
- 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
- Allergy plus Sinus Headache
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
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 |
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 |
|---|---|---|---|---|---|---|
| Premier Value | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2e8fbe-c1c3-79b1-e063-6394a90a4d73 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2dfcc3-e599-3102-e063-6394a90ad54a | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39 | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f42644-045b-c4b3-e063-6294a90a48fd | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f45499-bf14-03e4-e063-6394a90a535c | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f | 2025-12-29 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a5551-4989-d8fe-e063-6394a90aeabf | 2025-12-29 | Warnings | M012 |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2acaa-2cc8-a999-e063-6294a90a15ce | 2025-12-29 | Warnings | M012 |
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a92ecc-6a9c-b569-e063-6394a90a8bcb | 2025-12-29 | Warnings | M012 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | a5ceab90-6885-4f3a-b001-97679e03c01b | 2025-12-29 | Warnings | M012 |
| Goodmeds Non-Drowsy Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | 32482083-3f51-41f4-8d20-bedf143e066d | 2025-12-29 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 77c16288-68c4-476c-995f-86f505663270 | 2025-12-29 | Warnings | M012 |
| Tusnel DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | fe457e6d-422d-496c-bcb9-33594f3c42ff | 2025-12-29 | Warnings | M012 |
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | M012 |
| Fortify | MENTHOL | Natures Formulae Health Products Ltd. | 781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd | 2025-12-29 | Warnings | M012 |
| Safetussin PM Nighttime Cough relief | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kramer Laboratories | 33dd2245-9abd-4b32-ac76-0f45a54c0f33 | 2025-12-29 | Warnings | M012 |
| Winco Foods Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | WinCo Foods, LLC | f54eb60d-c602-1272-e053-2995a90aa95a | 2025-12-28 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | ad4d74a8-a762-4378-9016-f7c83421073e | 2025-12-26 | Warnings | M012 |
| Sorbutuss NR | SORBUTUSS | Dextrum Laboratories Inc. | 304f1d5a-218c-51ae-e054-00144ff88e88 | 2025-12-26 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a28aa-00e9-8b9d-e063-6394a90ace2a | 2025-12-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1233575 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8 | 4 |
| 1233575 | acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8 | 4 |
| 1233575 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG Oral Tablet | SY | ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8 | 4 |
| 1233575 | APAP 325 MG / Diphenhydramine Hydrochloride 12.5 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83059-0162-1 | 83059016201 | 1 BLISTER PACK in 1 CARTON (83059-0162-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2026-09-11 | No | No | Current |