Cold Medicine
- Product NDC
- 63654-601
- 11-digit product format
- 636540601
- Labeler code
- 63654
- Product ID
- 63654-601_24b211e4-a9aa-47a2-e063-6394a90aa4d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Selder, S.A. de C.V.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-08-01
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 4; 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold Medicine
- Brand name suffix
- XL3 FORTE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ |
| Rxcui | 1193293 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63654-601-01 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | | 7 |
| 63654-601-02 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | | 7 |
| 63654-601-04 | Cold MedicineXL3 FORTE | 4 in 1 PACKET | TABLET | 4 | | 7 |
| 63654-601-10 | Cold MedicineXL3 FORTE | 1 in 1 BOX | TABLET | 1 | | 7 |
| 63654-601-20 | Cold MedicineXL3 FORTE | 2 in 1 BOX | TABLET | 2 | | 7 |
| 63654-601-50 | Cold MedicineXL3 FORTE | 50 in 1 BOX | TABLET | 50 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63654-601 | COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [SELDER, S.A. DE C.V.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241027_51dd467b-aae8-41fa-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63654-601-01 | 63654060101 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 63654-601-02 | 63654060102 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 63654-601-04 | 63654060104 | 4 in 1 PACKET | | | | | | Historical |
| 63654-601-10 | 63654060110 | 1 BLISTER PACK in 1 BOX (63654-601-10) / 10 TABLET in 1 BLISTER PACK (63654-601-01) | 1 blister pack | 2018-10-12 | 0000-00-00 | No | No | Current |
| 63654-601-20 | 63654060120 | 2 BLISTER PACK in 1 BOX (63654-601-20) / 10 TABLET in 1 BLISTER PACK (63654-601-02) | 2 blister pack | 2017-08-01 | 0000-00-00 | No | No | Current |
| 63654-601-50 | 63654060150 | 50 PACKET in 1 BOX (63654-601-50) / 4 TABLET in 1 PACKET (63654-601-04) | 50 packet | 2017-08-01 | 0000-00-00 | No | No | Current |