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 |
|---|---|---|---|---|---|---|
| CareOne Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e | 2026-08-04 | Warnings | M012 |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 3d8ce88e-9f40-4b58-a811-160ddbfb8112 | 2026-08-04 | Warnings | M012 |
| ValuRx Dye Free Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Shield Pharmaceuticals Corp | ca60a413-b02e-48ce-985d-4d415780c679 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Rite Aid Corporation | 20af2586-f8ac-47a3-9f8d-de255f919328 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 150b68ba-3ed4-4533-9118-74e76eaf6e48 | 2026-08-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | ce393bff-498b-42e6-a41c-bbfbc58fb42c | 2026-08-04 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 3b8662bf-3abb-4e54-af9c-5fa1d2e19003 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Family Dollar Services Inc | 74ee96f7-75ac-4b60-a2b8-13b050e23804 | 2026-08-04 | Warnings | M012 |
| Mucus Relief PE | GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cb1c1922-5dc6-520d-e77e-e951726d9701 | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | DOLGENCORP, LLC | 7a662caf-9cbb-4d55-b0b2-43f1f1289ec7 | 2026-08-04 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | da053bc3-e790-4ae9-a406-2629640e97e7 | 2026-08-04 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 4d199dc7-253f-48fd-a77d-f8b10f724dd1 | 2026-08-04 | Warnings | M012 |
| daytime nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 80aae1c3-a616-442b-842e-177db957a69c | 2026-08-04 | Warnings | M012 |
| Mucus Relief D | GUAIFENESIN, PSEUDOEPHEDRINE HCL | Meijer Distribution Inc | 383281d7-0d25-4423-ace2-d2985f2c37d0 | 2026-08-03 | Warnings | M012 |
| equaline daytime and nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 8fc2389c-9657-4dbe-a32b-df8245fc67ca | 2026-08-03 | Warnings | M012 |
| Acetominophen, Dextromethorphan hydrobromide | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Private Limited | 5302bc6d-d947-31c3-e063-6294a90a09f3 | 2026-08-03 | Warnings | M012 |
| MUCINEX INSTASOOTHE COUGH | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 0d99237c-0b52-0af6-e063-6394a90aba14 | 2026-08-03 | Warnings | M012 |
| daytime nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 182a105b-bd49-42b5-b4e0-46e5ec0197e3 | 2026-08-03 | Warnings | M012 |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 05e089e7-8772-4bf4-914f-6a26067ee719 | 2026-08-03 | Warnings | M012 |
| Allergy | CHLORPHENIRAMINE MALEATE | Major Pharmaceuticals | 66b918d3-5c37-4889-b981-819ced8b6147 | 2026-08-03 | 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 |