Cold Medicine
- Product NDC
- 76095-011
- 11-digit product format
- 760950011
- Labeler code
- 76095
- Product ID
- 76095-011_24b2650e-08a2-0752-e063-6394a90a4b90
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Midway Importing, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-27
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 2; 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold Medicine
- Brand name suffix
- XL3
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ |
| Rxcui | 1046781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76095-011-20 | Cold MedicineXL3 | 2 in 1 BOX | TABLET | 2 | | 2 |
| 76095-011-20 | Cold MedicineXL3 | 10 in 1 BLISTER PACK | TABLET | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76095-011 | COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241027_e41b9beb-e274-5c02-e053-2995a90ad0f8.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 |
|---|
| 76095-011-20 | 76095001120 | 2 BLISTER PACK in 1 BOX (76095-011-20) / 10 TABLET in 1 BLISTER PACK | 2 blister pack | 2022-06-27 | 0000-00-00 | No | No | Current |