Sanaflu Xtra
- Product NDC
- 48201-001
- Requested package NDC
- 48201-001-12
- 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
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 250; 2; 10; 5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sanaflu Xtra
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 250 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 2 mg/1 |
| ACETAMINOPHEN | 10 mg/1 |
| CHLORPHENIRAMINE MALEATE | 5 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.
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 |