Sanaflu Xtra
- Product NDC
- 48201-001
- 11-digit product format
- 482010001
- Labeler code
- 48201
- Product ID
- 48201-001_42404180-fa1a-fcf6-e063-6394a90a281f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- GRANDALL DISTRIBUTING, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-04-30
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
- Active strength
- 10; 5; 250; 2 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
- Sanaflu Xtra
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 250 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1193292 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4af8a566-5251-4d46-8692-87a3a0748334 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48201-001-12 | Sanaflu Xtra | 12 in 1 BOX | CAPSULE, GELATIN COATED | 12 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48201-001 | SANAFLU XTRA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [GRANDALL DISTRIBUTING, LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240124_4af8a566-5251-4d46-8692-87a3a0748334.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 |
|---|---|---|---|---|---|---|
| Walgreens Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | 667418fc-a3ab-cbc7-e053-2a91aa0a2023 | 2024-11-13 | Warnings | M013 |
| Up and Up Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Target Corporation | a72eef45-b985-638a-e053-2995a90aa20a | 2024-11-13 | Warnings | M013 |
| Signature Care Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Safeway, Inc | 6e120024-475a-73af-e053-2a91aa0a42a6 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Kroger Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Kroger Company | 6d858b0e-a3c8-2686-e053-2991aa0acc06 | 2024-11-13 | Warnings | M013 |
| TopCare Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Topco Associates LLC | 639f9d57-f26a-708a-e053-2a91aa0a6962 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | H. E. Butt Grocery Company | 6418cde9-607b-4ca1-e053-2991aa0a9170 | 2024-11-13 | Warnings | M013 |
| Bromo Seltzer | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID | Tower Laboratories Ltd | 8ff88ee1-e33e-4051-992f-24e2720c48ce | 2024-11-13 | Warnings | M013 |
| Care One Original Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Foodhold U.S.A. | 8f662c51-d2fa-6458-e053-2995a90ac6fd | 2024-11-13 | Warnings | M013 |
| Top Value Effervescent Pain Relief | APIRIN, CITRIC ACID, SODIUM BICARBONATE | Tower Laboratories Ltd | 43c7f435-735c-3fab-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| DG Health Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | DOLGENCORP, INC | 8f1343d5-2884-3a14-e053-2a95a90a2f90 | 2024-11-13 | Warnings | M013 |
| Good Sense Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Good Sense | cd25b0c3-0134-beef-e053-2a95a90a092b | 2024-11-13 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Discount Drug Mart, Inc | 8bc65603-1dbf-30ab-e053-2995a90a7c15 | 2024-11-13 | Warnings | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | 8aab905b-5fe7-dddb-e053-2995a90a6c6f | 2024-11-13 | Warnings | M013 |
| Publix Fast Relief Effervescent | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Publix Super Markets Inc. | 73051f16-2569-7394-e053-2991aa0a5359 | 2024-11-13 | Warnings | M013 |
| Quality Choice Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 70d265de-ff94-e0e4-e053-2a91aa0a962a | 2024-11-13 | Warnings | M013 |
| Quality Choice Extra Strength Effervescent Antacid and Pain Relief | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | Chain Drug Marketing Association | 9f7d0c96-a561-a8a0-e053-2995a90a250b | 2024-11-13 | Warnings | M013 |
| WinCo Foods Effervescent Antacid and Pain Relief | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET | WinCo Foods, LLC | 0c8a755a-089f-477f-97e9-0dd6fdfbe99d | 2024-11-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Kroger Company | 8fb19444-f0e0-4d26-81e8-6a4b835056d8 | 2024-11-12 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 59d01f72-4575-48e2-b914-b6a6456ca7d2 | 2024-11-11 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Kroger Company | d181560c-1c39-4f2e-8a17-996224ca040f | 2024-11-09 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1193292 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 4af8a566-5251-4d46-8692-87a3a0748334 | 10 |
| 1193292 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 4af8a566-5251-4d46-8692-87a3a0748334 | 10 |
| 1193292 | APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 4af8a566-5251-4d46-8692-87a3a0748334 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48201-001-12 | 48201000112 | 12 CAPSULE, GELATIN COATED in 1 BOX (48201-001-12) | 2015-04-30 | 0000-00-00 | No | No | Current |