Severe Allergy Plus Sinus Headache
- Product NDC
- 49035-543
- 11-digit product format
- 490350543
- Labeler code
- 49035
- Product ID
- 49035-543_7bbdecf8-4f5d-4953-9749-5db21092bc11
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-06-27
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 25; 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
- 2026-12-31
- 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
- Severe Allergy Plus Sinus Headache
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 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 |
|---|---|
| 1046751 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1a1f41c4-5430-4cff-873e-6547dadc8779 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-543-09 | Severe Allergy Plus Sinus Headache | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 13 | |
| 49035-543-09 | Severe Allergy Plus Sinus Headache | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 13 | |
| 49035-543-41 | Severe Allergy Plus Sinus Headache | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49035-543-09 | EA - Each | 49035-543 | fa96fb47-bf70-40d7-a0d1-0d005475d905 | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-543 | SEVERE ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 12 | Current NDC, Legacy NDC, 3 package rows | 20241027_1a1f41c4-5430-4cff-873e-6547dadc8779.zip |
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 |
|---|---|---|---|---|---|---|
| Mucus Relief Immediate Release | GUAIFENESIN | Allegiant Health | 221d64a2-b8c7-435a-aae4-fb58fd38108f | 2019-03-26 | Warnings | M012 |
| Sleep Tabs For Nighttime use | DIPHENHYDRAMINE HCL TABLETS | Allegiant Health | 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d | 2018-12-26 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Allegiant Health | 4305ad50-d2a5-4d3e-9d92-cbf26e856a16 | 2018-12-26 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL 25 MG | Allegiant Health | dbbc535f-515a-4d9b-b799-34e60f5230bb | 2018-12-21 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Allegiant Health | c2823bad-540f-4662-8dcc-58e9f0d94efb | 2018-11-07 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength Non-Drowsy | PHENYLEPHRINE 10 MG | Allegiant Health | 7aef00df-816a-4ea2-a2ad-beed66dd2fe4 | 2018-11-07 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a58bfb14-28f9-4425-a5a5-aaff4847c979 | 2018-03-14 | Warnings | M012 |
| Chlorpheniramine maleate 4mg | CHLORPHENIRAMINE MALEATE 4MG | Athlete's Needs, Inc. | 4d974959-25fc-4707-9b72-9afbf47b76f1 | 2017-11-14 | Warnings | M012 |
| Cold Medicine | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Marc Glassman, Inc. | 2051247f-ce64-4cf5-b449-9ca14c43ab86 | 2016-12-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046751 | acetaminophen 325 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 13 |
| 1046751 | acetaminophen 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 13 |
| 1046751 | APAP 325 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-543-09 | 49035054309 | 2 BLISTER PACK in 1 CARTON (49035-543-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2007-06-27 | 0000-00-00 | No | No | Current |
| 49035-543-41 | 49035054341 | 10 TABLET, FILM COATED in 1 BLISTER PACK (49035-543-41) | 2007-06-27 | 0000-00-00 | No | No | Current |