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 |
|---|---|---|---|---|---|---|
| ORIGINAL Nasal PUMP MIST No Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | ac27fd75-4fe4-433c-a434-2dac16c895c7 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WINCO FOODS, LLC | a1367804-37c9-4906-858f-8feeb748d8d3 | 2026-08-07 | Warnings | M012 |
| Severe Congestion Nasal Anti-Drip Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | a09c2d02-334a-4840-b2d0-327121cec994 | 2026-08-07 | Warnings | M012 |
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| NICOTINE GUM | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 4e88dab4-8e13-f074-e063-6394a90a3908 | 2026-08-06 | Warnings | M012 |
| Oneoo Nicotine Gum (Mint) | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 54b1329b-b422-29a5-e063-6294a90a8780 | 2026-08-06 | Warnings | M012 |
| Sine Aid PEAK MISERY | OXYMETAZOLINE HYDROCHLORIDE | Infirst Healthcare Inc. | 586a2a14-7048-0c8b-e063-6394a90a65b7 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| TOPCARE DAY TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | d1b89d17-b3b9-4133-88a3-8cd7c4efafa9 | 2026-08-05 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 507284c3-cad9-d65c-e063-6394a90a58a8 | 2026-08-05 | Warnings | M012 |
| cough and cold relief HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | United Natural Foods, Inc. dba UNFI | 90482e7a-d7c7-4127-972d-5ee55e55ed1c | 2026-08-04 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Better Living Brands, LLC | 33f34aa2-3b37-4e51-8428-4a12708aa064 | 2026-08-04 | 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 |