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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | 4c9cca86-41bf-1635-e063-6294a90a17fb | 2026-03-09 | Warnings | M012 |
| sinus pressure and pain and cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Target Corporation | 488588f3-62d3-4248-937a-1c200792b5f1 | 2026-03-09 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 447a8753-96bd-676a-e063-6394a90a48f2 | 2026-03-06 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 51e34704-5e6b-4e80-836c-ddbc24a451b2 | 2026-03-06 | Warnings | M012 |
| Medi-First Plus Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 20f58b0b-c123-477f-a62c-fa5423e23f93 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Sportpharm LLC | 7f4e8d37-8c6b-4849-b86c-4335a0bcac1c | 2026-03-06 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Kit | DAYTIME AND NIGHTTIME COLD AND FLU KIT | Allegiant Health | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Better Living Brands, LLC | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 2026-03-06 | Warnings | M012 |
| Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution, Inc. | 87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e | 2026-03-06 | Warnings | M012 |
| RYNEX PE | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | EDWARDS PHARMACEUTICALS, INC. | 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef | 2026-03-05 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 042f9449-4af0-4b15-bb3e-236afeb1e11f | 2026-03-05 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Amerisource Bergen | 087a3a0b-8d3f-45ed-8807-0af47b446cac | 2026-03-05 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | NUVICARE LLC | 6c4bc7d1-09d9-4311-8457-a1d47ab02a5a | 2026-03-05 | Warnings | M012 |
| Allergy Relief childrens | DIPHENHYDRAMINE HCL | WALMART INC. | dceb99a9-4aa3-4acc-b632-9a4ba8c87919 | 2026-03-04 | Warnings | M012 |
| AMAZON Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMAZON.COM SERVICES LLC | 26101105-a6cf-4b51-a639-9d078542fea3 | 2026-03-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 3a976e90-c6af-4414-984e-9987158c9e98 | 2026-03-04 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | 714e93ec-0aa9-4be2-9311-399e82f148e0 | 2026-03-04 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | d1131759-dd2e-4c06-bb73-92dd975f5511 | 2026-03-04 | Warnings | M012 |
| AMAZON Maximim Strength Adult Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AMAZON.COM SERVICES LLC | 6bbe8cc9-7a60-4476-b5cf-b13c5bebff26 | 2026-03-04 | Warnings | M012 |
| Severe Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5a1dfaf3-370d-4ac7-a72d-a48863a35741 | 2026-03-04 | 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 |